Clinical Trials in France / NCT06571552
Recruiting
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Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
NCT06571552 · tracked via the Priya Life Science France tracker
Condition(s) studied
HyperfibrinogenemiaHemostatic Disorder
Investigational drug(s) / intervention(s)
Single Plasma Exchange followed by Double Filtration Plasmapheresis
Single Plasma Exchange followed by Double Filtration Plasmapheresis: Double Filtration Plasmapheresis followed by Single Plasma Exchange
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange — Day 0, before the session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange — Day 0, before the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange — Day 0, end of session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange — Day 0, end of session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange — Day 0, 1 hour after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange — Day 0, 1 hour after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange — Day 0, 4 hours after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange — Day 0, 4 hours after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange — Day 1
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange — Day 1
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange — Day 3
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange — Day 3
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange — Month 1, Day 1, 1 hour after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange — Month 1, Day 1, 1 hour after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange — Month 1, Day 4, 4 hours after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange — Month 1, Day 4, 4 hours after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange — Month 1, Day 3
Clauss functional method, g/L - Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange — Month 1, Day 3
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis — Day 0, before the session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis — Day 0, before the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis — Day 0, end of session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis — Day 0, end of session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis — Day 0, 1 hour after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis — Day 0, 1 hour after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis — Day 0, 4 hours after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis — Day 0, 4 hours after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis — Day 1
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis — Day 1
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis — Day 3
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis — Day 3
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis — Month 1, Day 1, 1 hour after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis — Month 1, Day 1, 1 hour after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis — Month 1, Day 1, 4 hours after the session
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis — Month 1, Day 1, 4 hours after the session
Automated thrombin generation test on Génésia®. - Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis — Month 1, Day 3
Clauss functional method, g/L - Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis — Month 1, Day 3
Automated thrombin generation test on Génésia®.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Nîmes | Nîmes | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06571552 on ClinicalTrials.gov ↗ ← All trials in France