Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Single Plasma Exchange followed by Double Filtration Plasmapheresis

    Procedure/Surgery

    Double Filtration Plasmapheresis followed by Single Plasma Exchange

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: Patients benefitting from Single Plasma Exchange followed by Double Filtration PlasmapheresisActive comparator 1 intervention
Group B: Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma ExchangeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange

Clauss functional method, g/L

Time frame
Day 0, before the session
2

Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange

Automated thrombin generation test on Génésia®.

Time frame
Day 0, before the session
3

Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange

Clauss functional method, g/L

Time frame
Day 0, end of session
4

Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange

Automated thrombin generation test on Génésia®.

Time frame
Day 0, end of session

Secondary outcomes

1

Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells

Quantitative, per microliter

Time frame
Day 0, Hour 0
2

Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

Quantitative, per microliter

Time frame
Day 0, Hour 1
3

Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

Quantitative, per microliter

Time frame
Day 0, Hour 4
4

Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

Quantitative, per microliter

Time frame
Day 1

Other outcomes

1

Gender of patients

Recorded as Male, Female, Nonbinary

Time frame
Day 0, Hour 0
2

Age of patients

Recorded in years

Time frame
Day 0, Hour 0
3

Weight of patients

Recorded in kilos

Time frame
Day 0, Hour 0
4

Height of patients

Recorded in centimeters

Time frame
Day 0, Hour 0

Sponsors and contacts

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