Actively Recruiting
Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-12-20
6
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and eligible for single plasma exchange or double filtration plasmapheresis according to international guidelines
- Therapeutic plasmapheresis performed with regional citrate anticoagulation
- Patients aged 18 years or older
- Patients affiliated with or benefiting from a social security scheme
- Signed free, informed, and written consent by the participant and investigator before any research examinations
You will not qualify if you...
- Patients treated with oral anticoagulants or anti-platelet agents
- Patients treated for hypercholesterolaemia or hypertriglyceridaemia, hyperviscosity, acquired haemophilia, or nephrotic syndrome
- Patients requiring substitution with fresh frozen plasma for disease treatment
- Patients currently in an exclusion period for another study
- Patients under court protection, guardianship, or curatorship
- Patients unable to give consent or receive informed information
- Pregnant or breast-feeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Nîmes
Nîmes, France, 30029
Actively Recruiting
Research Team
O
Olivier MORANNE, Professor
CONTACT
A
Anissa MEGZARI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here