Observational Study of the Use of octaplasLG®.

March 18, 2021 updated by: Octapharma

Observational, Real-life Study of the Use of octaplasLG®.

This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.

Study Overview

Status

Status

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

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

Prospective, non-interventional, multicentre study meeting a post-marketing need. The data will be collected in all patients who have received at least one infusion of octaplasLG®.

The duration of follow-up is limited to the duration of treatment with octaplasLG® plus 24 h of monitoring after cessation of treatment.

Characteristics of the use of octaplasLG® (indication for the transfusion, degree of urgency, characteristics of plasma infusions, patient characteristics, number of iso-group and/or compatible units administered, tolerance criteria (adverse effects), and efficacy criteria (for patients with confirmed diagnosis of TTP--time to normalization of platelet count) will be collected.

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.
Observational

Enrollment (Actual)

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.
263

Contacts and Locations

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

Study Locations

  • France
      • Avignon, France, 84902
        • CH Henri Duffaut
      • Brest, France, 29019
        • Hopital De La Cavale Blanche
      • Bron, France, 69500
        • Hôpital Louis Pradel
      • Caluire-et-Cuire, France, 69641
        • Infirmerie Protestante de Lyon
      • Lyon, France, 67347
        • Hospices Civils de Lyon Hôpital Edouard Herriot
      • Marseille, France, 13385
        • Hôpital de la Conception
      • Paris, France
        • APHP Hôpital Cochin
      • Paris, France, 75651
        • APHP Hôpital Pitié Salpêtrière
      • Rouen, France, 76031
        • CHU hopitaux de rouen
      • Saint-Étienne, France, 42055
        • CHRU Hôpital Nord
      • Suresnes, France, 92150
        • Hopital Foch
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Tours, France, 37000
        • CHRU Bretonneau
      • Vandœuvre-lès-Nancy, France, 54511
        • CHU de Nancy

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Analyses will be carried out on all patients included, i.e. who have received at least one unit of octaplasLG®. This population will be stratified based on the different product indications.

For the population defined as that of patients with TTP, only those patients for whom the investigator has indicated a confirmed diagnosis of idiopathic TTP will be included in the efficacy analysis (see secondary objective).

Description

Inclusion Criteria:

  1. The patient is treated with octaplasLG® (receiving at least 1 unit of 200 ml octaplasLG®)

  2. In accordance with Reference Methodology MR-003, the patient of legal age must be individually informed through an information sheet, and must not oppose participating in this non-interventional study (with no collection of consent). If the patient is unable to receive the information and express any opposition, family members or the trusted person receive the information and must not oppose the collection of data*. For minor patients, one of the holders of parental authority receive the information and must not oppose the collection of data.

    • However, the patient in question will be informed if his/her condition later allows.

Exclusion Criteria:

1) Patient's refusal to participate

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients Receiving octaplasLG®
The data will be collected in all patients who have received at least one infusion of octaplasLG®
Drug: octaplasLG®
Data will be collected in all patients who have received at least one infusion of octaplasLG®

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
Indication for the transfusion of octaplasLG®
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Indication for the transfusion of octaplasLG®
From start of treatment to 24 hours following treatment with octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
From start of treatment to 24 hours following treatment with octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
From start of treatment to 24 hours following treatment with octaplasLG®
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
From start of treatment to 24 hours following treatment with octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
From start of treatment to 24 hours following treatment with octaplasLG®

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
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma including allergic immunological type (e.g. TRALI) and other events (infections, related to the PE procedure (e.g. case of transfusion-associated circulatory overload [TACO], citrate reaction, etc.).
From start of treatment to 24 hours following treatment with octaplasLG®
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)
Time Frame: From start of treatment to 24 hours following treatment with octaplasLG®
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)
From start of treatment to 24 hours following treatment with octaplasLG®

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.
Octapharma

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.
March 2, 2018

Primary Completion (ACTUAL)

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.
January 14, 2021

Study Completion (ACTUAL)

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.
January 14, 2021

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).
November 30, 2017

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.
December 5, 2017

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.
December 12, 2017

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 19, 2021

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.
March 18, 2021

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.
March 1, 2021

More Information

Terms related to this study

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.
  • TMA POOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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