Comparing two techniques for treating coagulation disorders caused by plasmapheresis
Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
NA · Centre Hospitalier Universitaire de Nīmes · NCT06571552
This study is testing two different plasmapheresis techniques to see how they affect blood clotting in adults who need ongoing treatment for coagulation disorders.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes (other) |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT06571552 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of two different plasmapheresis techniques—Single Plasma Exchange (SPE) and Double Filtration Plasmapheresis (DFPP)—on coagulation disorders. It aims to document the changes in hemostatic factors and their kinetics following these treatments, as current data is limited and often focuses only on pre- and post-treatment coagulation factor assays. The study will include patients over 18 years old who are undergoing chronic therapeutic plasmapheresis without renal failure. By understanding the impact of these techniques on hemostasis, the study seeks to clarify when and how to correct coagulation deficiencies that may arise post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing chronic therapeutic plasmapheresis without renal failure.
Not a fit: Patients on anticoagulants, those with certain hematological conditions, or those requiring fresh frozen plasma substitution may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of coagulation disorders in patients undergoing plasmapheresis, potentially reducing the risk of bleeding complications.
How similar studies have performed: While some studies have explored coagulation changes with plasmapheresis, this specific comparison of SPE and DFPP is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nîmes
- CHU de Nîmes — Nîmes, France (RECRUITING)
Study contacts
- Principal investigator: Emilie PAMBRUN, Docteur — Nîmes University Hospital
- Study coordinator: Olivier MORANNE, Professor
- Email: olivier.moranne@chu-nimes.fr
- Phone: +334.66.68.31.49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperfibrinogenemia, Hemostatic Disorder, Double Filtration Plasmapheresis, Single Plasma Exchange