Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study. (APHERCOAG)

December 18, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors. It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding. However the methods of correcting these disorders are debatable. Finally, it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected. Haemostasis is probably not based solely on the level of blood fibrinogen, but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage. No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, according to session type and fibrinogen level at the end of the session. The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and propose preventive measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Some data are available on changes in circulating haemostasis factors with the Single Plasma Exchange technique and the Double Filtration Plasmapheresis; however, most often these studies are carried out in specific clinical situations where other haemostasis disorders may be present, such as severe renal failure. Furthermore, in these studies, assessment of changes in haemostasis is often limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors, whose molecular weight and half-life vary widely. To date, there is no clear consensus/recommendation on the management of haemostasis disorders secondary to therapeutic apheresis. The need to correct haemostasis disorders caused by therapeutic apheresis also appears to be consensual in cases of active bleeding.The methods of correcting haemostasis disorders can also be discussed between infusion of coagulation factor and fresh frozen plasma. Finally, apart from these clinical situations, it is not clear when changes in haemostasis associated with coagulation factor deficiency should be corrected. There are no studies available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, depending on the type of session and the fibrinogen level at the end of the session. The hypothesis of our research is that the existence of a link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and to propose preventive measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nîmes, France, 30029
        • Recruiting
        • CHU de Nîmes
        • Principal Investigator:
          • Olivier MORANNE, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and who can be treated with single plasma exchange (SPE) or double filtration plasmapheresis (DFPP) in accordance with the international recommendations.
  • Therapeutic plasmapheresis with regional citrate anticoagulation.
  • Patients over 18 years of age.
  • Patient affiliated to or benefiting from a social security scheme.
  • Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

  • Patients treated with oral anticoagulants or anti-platelet agents.
  • Patients treated for hypercholesterolaemia or hypertriglyceridaemia; hyperviscosity, acquired haemophilia or nephrotic syndrome.
  • Indication for substitution with fresh frozen plasma (FFP) for the treatment of the disease.
  • Patient in an exclusion period determined by another study.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.
  • Pregnant or breast-feeding patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Patients benefitting from Single Plasma Exchange followed by Double Filtration Plasmapheresis
For the patients in this group, the first cycle (T1) will consist of Single Plasma Exchange and the second cycle (T2) of Double Filtration Plasmapheresis.
Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis
Double Filtration Plasmapheresis followed by Single Plasma Exchange
Active Comparator: Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma Exchange
For the patients in this group, the first cycle (T1) will consist of Double Filtration Plasmapheresis and the second cycle (T2) of Single Plasma Exchange.
Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis
Double Filtration Plasmapheresis followed by Single Plasma Exchange

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange
Time Frame: Day 0, before the session
Clauss functional method, g/L
Day 0, before the session
Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange
Time Frame: Day 0, before the session
Automated thrombin generation test on Génésia®.
Day 0, before the session
Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange
Time Frame: Day 0, end of session
Clauss functional method, g/L
Day 0, end of session
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange
Time Frame: Day 0, end of session
Automated thrombin generation test on Génésia®.
Day 0, end of session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, 1 hour after the session
Clauss functional method, g/L
Day 0, 1 hour after the session
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, 1 hour after the session
Automated thrombin generation test on Génésia®.
Day 0, 1 hour after the session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, 4 hours after the session
Clauss functional method, g/L
Day 0, 4 hours after the session
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, 4 hours after the session
Automated thrombin generation test on Génésia®.
Day 0, 4 hours after the session
Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
Time Frame: Day 1
Clauss functional method, g/L
Day 1
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
Time Frame: Day 1
Automated thrombin generation test on Génésia®.
Day 1
Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
Time Frame: Day 3
Clauss functional method, g/L
Day 3
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
Time Frame: Day 3
Automated thrombin generation test on Génésia®.
Day 3
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Time Frame: Month 1, Day 1, 1 hour after the session
Clauss functional method, g/L
Month 1, Day 1, 1 hour after the session
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
Time Frame: Month 1, Day 1, 1 hour after the session
Automated thrombin generation test on Génésia®.
Month 1, Day 1, 1 hour after the session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Time Frame: Month 1, Day 4, 4 hours after the session
Clauss functional method, g/L
Month 1, Day 4, 4 hours after the session
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
Time Frame: Month 1, Day 4, 4 hours after the session
Automated thrombin generation test on Génésia®.
Month 1, Day 4, 4 hours after the session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Time Frame: Month 1, Day 3
Clauss functional method, g/L
Month 1, Day 3
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
Time Frame: Month 1, Day 3
Automated thrombin generation test on Génésia®.
Month 1, Day 3
Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, before the session
Clauss functional method, g/L
Day 0, before the session
Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, before the session
Automated thrombin generation test on Génésia®.
Day 0, before the session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, end of session
Clauss functional method, g/L
Day 0, end of session
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, end of session
Automated thrombin generation test on Génésia®.
Day 0, end of session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, 1 hour after the session
Clauss functional method, g/L
Day 0, 1 hour after the session
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, 1 hour after the session
Automated thrombin generation test on Génésia®.
Day 0, 1 hour after the session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, 4 hours after the session
Clauss functional method, g/L
Day 0, 4 hours after the session
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 0, 4 hours after the session
Automated thrombin generation test on Génésia®.
Day 0, 4 hours after the session
Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 1
Clauss functional method, g/L
Day 1
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 1
Automated thrombin generation test on Génésia®.
Day 1
Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 3
Clauss functional method, g/L
Day 3
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
Time Frame: Day 3
Automated thrombin generation test on Génésia®.
Day 3
Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
Time Frame: Month 1, Day 1, 1 hour after the session
Clauss functional method, g/L
Month 1, Day 1, 1 hour after the session
Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
Time Frame: Month 1, Day 1, 1 hour after the session
Automated thrombin generation test on Génésia®.
Month 1, Day 1, 1 hour after the session
Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
Time Frame: Month 1, Day 1, 4 hours after the session
Clauss functional method, g/L
Month 1, Day 1, 4 hours after the session
Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
Time Frame: Month 1, Day 1, 4 hours after the session
Automated thrombin generation test on Génésia®.
Month 1, Day 1, 4 hours after the session
Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
Time Frame: Month 1, Day 3
Clauss functional method, g/L
Month 1, Day 3
Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
Time Frame: Month 1, Day 3
Automated thrombin generation test on Génésia®.
Month 1, Day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin
Time Frame: Day 0, Hour 0
Quantitative, grams per liter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Time Frame: Day 0, Hour 1
Quantitative, grams per liter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Time Frame: Day 0, Hour 4
Quantitative, grams per liter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Time Frame: Day 1
Quantitative, grams per liter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Time Frame: Day 3
Quantitative, grams per liter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Platelets
Time Frame: Day 0, Hour 0
Quantitative, %
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Time Frame: Day 0, Hour 1
Quantitative, %
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Time Frame: Day 0, Hour 4
Quantitative, %
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Time Frame: Day 1
Quantitative, %
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Time Frame: Day 3
Quantitative, %
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Basophils
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit
Time Frame: Day 0, Hour 0
Quantitative, %
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Time Frame: Day 0, Hour 1
Quantitative, %
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Time Frame: Day 0, Hour 4
Quantitative, %
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Time Frame: Day 1
Quantitative, %
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Time Frame: Day 3
Quantitative, %
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Time Frame: Day 0, Hour 0
Quantitative, %
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Time Frame: Day 0, Hour 1
Quantitative, %
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Time Frame: Day 0, Hour 4
Quantitative, %
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Time Frame: Day 1
Quantitative, %
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Time Frame: Day 4
Quantitative, %
Day 4
Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Time Frame: Day 0, Hour 0
Quantitative, in pg
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Time Frame: Day 0, Hour 1
Quantitative, in pg
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Time Frame: Day 0, Hour 4
Quantitative, in pg
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Time Frame: Day 1
Quantitative, in pg
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Time Frame: Day 3
Quantitative, in pg
Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 0, Hour 0
Quantitative, in g/L
Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 0, Hour 1
Quantitative, in g/L
Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 0, Hour 4
Quantitative, in g/L
Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 1
Quantitative, in g/L
Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 3
Quantitative, in g/L
Day 3
Serum albumin before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
Quantitative, in g/dL
Day 0, Hour 0
Serum albumin after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
Quantitative, in g/dL
Day 0, Hour 1
Serum albumin after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
Quantitative, in g/dL
Day 0, Hour 4
Serum albumin after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
Quantitative, in g/dL
Day 1
Serum albumin after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
Quantitative, in g/dL
Day 3
Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
In seconds
Day 0, Hour 0
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
In seconds
Day 0, Hour 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
In seconds
Day 0, Hour 4
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
In seconds
Day 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
In seconds
Day 3
Factors VIII, IX, XI and XII before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
By 1-stage APTT-based Factor assay, in seconds
Day 0, Hour 0
Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
By 1-stage APTT-based Factor assay, in seconds
Day 0, Hour 1
Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
By 1-stage APTT-based Factor assay, in seconds
Day 0, Hour 4
Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
By 1-stage APTT-based Factor assay, in seconds
Day 1
Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
By 1-stage APTT-based Factor assay, in seconds
Day 3
Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
Prothrombin assay, in seconds
Day 0, Hour 0
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
Prothrombin assay, in seconds
Day 0, Hour 1
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
Prothrombin assay, in seconds
Day 0, Hour 4
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
Prothrombin assay, in seconds
Day 1
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
Prothrombin assay, in seconds
Day 3
D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
By enzyme-linked immunosorbent assay (ELISA) method
Day 0, Hour 0
D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
By enzyme-linked immunosorbent assay (ELISA) method
Day 0, Hour 1
D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
By enzyme-linked immunosorbent assay (ELISA) method
Day 0, Hour 4
D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
By enzyme-linked immunosorbent assay (ELISA) method
Day 1
D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
By enzyme-linked immunosorbent assay (ELISA) method
Day 3
Platelet function test before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
ADP/collagen and adrenalin/collagen cartridges.
Day 0, Hour 0
Platelet function test after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
ADP/collagen and adrenalin/collagen cartridges.
Day 0, Hour 1
Platelet function test after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
ADP/collagen and adrenalin/collagen cartridges.
Day 0, Hour 4
Platelet function test after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
ADP/collagen and adrenalin/collagen cartridges.
Day 1
Platelet function test after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
ADP/collagen and adrenalin/collagen cartridges.
Day 3
von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
Binding to platelet membrane glycoprotein Ib
Day 0, Hour 0
von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
Binding to platelet membrane glycoprotein Ib
Day 0, Hour 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
Binding to platelet membrane glycoprotein Ib
Day 0, Hour 4
von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
Binding to platelet membrane glycoprotein Ib
Day 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
Binding to platelet membrane glycoprotein Ib
Day 3
Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 0, Hour 0
Triggered by 1 pM tissue factor
Day 0, Hour 0
Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 0, Hour 1
Triggered by 1 pM tissue factor
Day 0, Hour 1
Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 0, Hour 4
Triggered by 1 pM tissue factor
Day 0, Hour 4
Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 1
Triggered by 1 pM tissue factor
Day 1
Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 3
Triggered by 1 pM tissue factor
Day 3
Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 0
Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)
Day 0, Hour 0
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 1
Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)
Day 0, Hour 1
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
Time Frame: Day 0, Hour 4
Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)
Day 0, Hour 4
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
Time Frame: Day 1
Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)
Day 1
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
Time Frame: Day 3
Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)
Day 3
Complete blood count before the double filtration plasmapheresis session : White blood cells
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : White blood cells
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : White blood cells
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : White blood cells
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : White blood cells
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Red blood cells
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Time Frame: Day 4
Quantitative, per microliter
Day 4
Complete blood count before the double filtration plasmapheresis session : Hemoglobin
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Platelets
Time Frame: Day 0, Hour 0
Quantitative, %
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Platelets
Time Frame: Day 0, Hour 1
Quantitative, %
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Platelets
Time Frame: Day 0, Hour 4
Quantitative, %
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Platelets
Time Frame: Day 1
Quantitative, %
Day 1
Complete blood count after the double filtration plasmapheresis session : Platelets
Time Frame: Day 3
Quantitative, %
Day 3
Complete blood count before the double filtration plasmapheresis session : Neutrophils
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Lymphocytes
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Monocytes
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Monocytes
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Monocytes
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Monocytes
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Monocytes
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Eosinophils
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Basophils
Time Frame: Day 0, Hour 0
Quantitative, per microliter
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Basophils
Time Frame: Day 0, Hour 1
Quantitative, per microliter
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Basophils
Time Frame: Day 0, Hour 4
Quantitative, per microliter
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Basophils
Time Frame: Day 1
Quantitative, per microliter
Day 1
Complete blood count after the double filtration plasmapheresis session : Basophils
Time Frame: Day 3
Quantitative, per microliter
Day 3
Complete blood count before the double filtration plasmapheresis session : Hematocrit
Time Frame: Day 0, Hour 0
Quantitative, %
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Time Frame: Day 0, Hour 1
Quantitative, %
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Time Frame: Day 0, Hour 4
Quantitative, %
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Time Frame: Day 1
Quantitative, %
Day 1
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Time Frame: Day 3
Quantitative, %
Day 3
Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume
Time Frame: Day 0, Hour 0
Quantitative, fL
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Time Frame: Day 0, Hour 1
Quantitative, fL
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Time Frame: Day 0, Hour 4
Quantitative, fL
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Time Frame: Day 1
Quantitative, fL
Day 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Time Frame: Day 3
Quantitative, fL
Day 3
Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Time Frame: Day 0, Hour 0
Quantitative, pg
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Time Frame: Day 0, Hour 1
Quantitative, pg
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Time Frame: Day 0, Hour 4
Quantitative, pg
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Time Frame: Day 1
Quantitative, pg
Day 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Time Frame: Day 3
Quantitative, pg
Day 3
Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 0, Hour 0
Quantitative, g/L
Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 0, Hour 1
Quantitative, g/L
Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 0, Hour 4
Quantitative, g/L
Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 1
Quantitative, g/L
Day 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Time Frame: Day 3
Quantitative, g/L
Day 3
Serum albumin before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
Quantitative, g/L
Day 0, Hour 0
Serum albumin after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
Quantitative, g/L
Day 0, Hour 1
Serum albumin after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
Quantitative, g/L
Day 0, Hour 4
Serum albumin after the double filtration plasmapheresis session.
Time Frame: Day 1
Quantitative, g/L
Day 1
Serum albumin after the double filtration plasmapheresis session.
Time Frame: Day 3
Quantitative, g/L
Day 3
Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
In seconds
Day 0, Hour 0
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
In seconds
Day 0, Hour 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
In seconds
Day 0, Hour 4
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
Time Frame: Day 1
In seconds
Day 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
Time Frame: Day 3
In seconds
Day 3
Factors VIII, IX, XI and XII before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
1-stage APTT-based Factor assay
Day 0, Hour 0
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
1-stage APTT-based Factor assay
Day 0, Hour 1
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
1-stage APTT-based Factor assay
Day 0, Hour 4
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
Time Frame: Day 1
1-stage APTT-based Factor assay
Day 1
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
Time Frame: Day 3
1-stage APTT-based Factor assay
Day 3
Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
Prothrombin assay, in seconds
Day 0, Hour 0
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
Prothrombin assay, in seconds
Day 0, Hour 1
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
Prothrombin assay, in seconds
Day 0, Hour 4
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Time Frame: Day 1
Prothrombin assay, in seconds
Day 1
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Time Frame: Day 3
Prothrombin assay, in seconds
Day 3
D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
By enzyme-linked immunosorbent assay (ELISA) method
Day 0, Hour 0
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
By enzyme-linked immunosorbent assay (ELISA) method
Day 0, Hour 1
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
By enzyme-linked immunosorbent assay (ELISA) method
Day 0, Hour 4
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
Time Frame: Day 1
By enzyme-linked immunosorbent assay (ELISA) method
Day 1
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
Time Frame: Day 3
By enzyme-linked immunosorbent assay (ELISA) method
Day 3
Platelet function test before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
ADP/collagen and adrenalin/collagen cartridges
Day 0, Hour 0
Platelet function test after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
ADP/collagen and adrenalin/collagen cartridges
Day 0, Hour 1
Platelet function test after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
ADP/collagen and adrenalin/collagen cartridges
Day 0, Hour 4
Platelet function test after the double filtration plasmapheresis session.
Time Frame: Day 1
ADP/collagen and adrenalin/collagen cartridges
Day 1
Platelet function test after the double filtration plasmapheresis session.
Time Frame: Day 3
ADP/collagen and adrenalin/collagen cartridges
Day 3
von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 0
Binding to platelet membrane glycoprotein Ib
Day 0, Hour 0
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 1
Binding to platelet membrane glycoprotein Ib
Day 0, Hour 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Time Frame: Day 0, Hour 4
Binding to platelet membrane glycoprotein Ib
Day 0, Hour 4
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Time Frame: Day 1
Binding to platelet membrane glycoprotein Ib
Day 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Time Frame: Day 3
Binding to platelet membrane glycoprotein Ib
Day 3
Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 0, Hour 0
Triggered by 1 pM tissue factor
Day 0, Hour 0
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 0, Hour 1
Triggered by 1 pM tissue factor
Day 0, Hour 1
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 0, Hour 4
Triggered by 1 pM tissue factor
Day 0, Hour 4
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 1
Triggered by 1 pM tissue factor
Day 1
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Time Frame: Day 3
Triggered by 1 pM tissue factor
Day 3
Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (thrombotic exploration version)
Time Frame: Day 0, Hour 0
Triggered by 5 pM tissue factor with response to purified thrombomodulin
Day 0, Hour 0
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
Time Frame: Day 0, Hour 1
Triggered by 5 pM tissue factor with response to purified thrombomodulin
Day 0, Hour 1
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
Time Frame: Day 0, Hour 4
Triggered by 5 pM tissue factor with response to purified thrombomodulin
Day 0, Hour 4
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
Time Frame: Day 1
Triggered by 5 pM tissue factor with response to purified thrombomodulin
Day 1
Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
Time Frame: Day 3
Triggered by 5 pM tissue factor with response to purified thrombomodulin
Day 3
Plasma Bank
Time Frame: Before Day 0, hour 0
Storage of unused tube ends
Before Day 0, hour 0
Plasma Bank
Time Frame: Day 0, hour1
Storage of unused tube ends
Day 0, hour1
Plasma Bank
Time Frame: Day 0, hour 4
Storage of unused tube ends
Day 0, hour 4
Plasma Bank
Time Frame: Day 1
Storage of unused tube ends
Day 1
Plasma Bank
Time Frame: Day 3
Storage of unused tube ends
Day 3
Plasma Bank
Time Frame: After end of session Day 0, H0
Storage of unused tube ends
After end of session Day 0, H0

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender of patients
Time Frame: Day 0, Hour 0
Recorded as Male, Female, Nonbinary
Day 0, Hour 0
Age of patients
Time Frame: Day 0, Hour 0
Recorded in years
Day 0, Hour 0
Weight of patients
Time Frame: Day 0, Hour 0
Recorded in kilos
Day 0, Hour 0
Height of patients
Time Frame: Day 0, Hour 0
Recorded in centimeters
Day 0, Hour 0
Diagnostic history of patients
Time Frame: Day 0, Hour 0
The patients' diagnostic history will be recorded
Day 0, Hour 0
Patient's apheresis protocol
Time Frame: Day 0, Hour 0
The apheresis protocol used, and parameters related to plasmapheresis will be recorded
Day 0, Hour 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emilie PAMBRUN, Docteur, Nîmes University Hospital
  • Principal Investigator: Sylvie BOUVIER, Docteur, Nîmes University Hospital
  • Principal Investigator: Jean-Christophe GRIS, Professor, Nîmes University Hospital
  • Principal Investigator: Mathieu FORTIER, Nîmes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2023-2/OM01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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