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

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: Recruiting
• Conditions: Hemostatic Disorder; Hyperfibrinogenemia
• Intervention / Treatment: Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis

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: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: +33466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Olivier MORANNE, Professor; Phone Number: +334.66.68.31.49; Email: olivier.moranne@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Principal Investigator: Olivier MORANNE, MD
    • Contact: Anne Clarisse SIMONET, PhD; Phone Number: 04.66.68.51.48; Email: anne.clarisse.simonet@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange	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	Automated thrombin generation test on Génésia®.	Day 0, before the session
Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange	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	Automated thrombin generation test on Génésia®.	Day 0, end of session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange	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	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	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	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	Clauss functional method, g/L	Day 1
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange	Automated thrombin generation test on Génésia®.	Day 1
Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange	Clauss functional method, g/L	Day 3
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange	Automated thrombin generation test on Génésia®.	Day 3
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange	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	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	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	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	Clauss functional method, g/L	Month 1, Day 3
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange	Automated thrombin generation test on Génésia®.	Month 1, Day 3
Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis	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	Automated thrombin generation test on Génésia®.	Day 0, before the session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis	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	Automated thrombin generation test on Génésia®.	Day 0, end of session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis	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	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	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	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	Clauss functional method, g/L	Day 1
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis	Automated thrombin generation test on Génésia®.	Day 1
Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis	Clauss functional method, g/L	Day 3
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis	Automated thrombin generation test on Génésia®.	Day 3
Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis	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	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	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	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	Clauss functional method, g/L	Month 1, Day 3
Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis	Automated thrombin generation test on Génésia®.	Month 1, Day 3

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender of patients	Recorded as Male, Female, Nonbinary	Day 0, Hour 0
Age of patients	Recorded in years	Day 0, Hour 0
Weight of patients	Recorded in kilos	Day 0, Hour 0
Height of patients	Recorded in centimeters	Day 0, Hour 0
Diagnostic history of patients	The patients' diagnostic history will be recorded	Day 0, Hour 0
Patient's apheresis protocol	The apheresis protocol used, and parameters related to plasmapheresis will be recorded	Day 0, Hour 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: 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

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Double Filtration Plasmapheresis; Single Plasma Exchange
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID 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