Comparing two techniques for treating coagulation disorders caused by plasmapheresis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Nîmes
  Nîmes, France, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.