About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
Single Plasma Exchange followed by Double Filtration Plasmapheresis
Procedure/SurgeryDouble Filtration Plasmapheresis followed by Single Plasma Exchange
Treatment groups
Trial outcomes
Primary outcomes
Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Secondary outcomes
Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Other outcomes
Gender of patients
Recorded as Male, Female, Nonbinary
Age of patients
Recorded in years
Weight of patients
Recorded in kilos
Height of patients
Recorded in centimeters
Sponsors and contacts
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