Clinical trial NCT06571552: Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
Official title: Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperfibrinogenemia
Hemostatic Disorder
Keywords: Double Filtration Plasmapheresis
Single Plasma Exchange
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients being monitored for chronic therapeutic plasmapheresis with regional citrate anticoagulation will be recruited from the Nephrology Department at Nîmes University Hospital. After receiving written informed consent (inclusion visit), patients will be randomized to determine the nature of their first cycle (single plasma exchange or double filtration plasmapheresis. The next cycle will vary accordingly: DFPP if the first cycle was single plasma exchange, and single plasma exchange if the first session was DFPP.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Some data are available on changes in circulating haemostasis factors with the Single Plasma Exchange technique and the Double Filtration Plasmapheresis; however, most often these studies are carried out in specific clinical situations where other haemostasis disorders may be present, such as severe renal failure. Furthermore, in these studies, assessment of changes in haemostasis is often limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors, whose molecular weight and half-life vary widely. To date, there is no clear consensus/recommendation on the management of haemostasis disorders secondary to therapeutic apheresis. The need to correct haemostasis disorders caused by therapeutic apheresis also appears to be consensual in cases of active bleeding.The methods of correcting haemostasis disorders can also be discussed between infusion of coagulation factor and fresh frozen plasma. Finally, apart from these clinical situations, it is not clear when changes in haemostasis associated with coagulation factor deficiency should be corrected. There are no studies available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, depending on the type of session and the fibrinogen level at the end of the session. The hypothesis of our research is that the existence of a link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and to propose preventive measures.

Eligibility 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.

Primary outcomes:
measure: Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange
timeFrame: Day 0, before the session
measure: Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange
timeFrame: Day 0, before the session
measure: Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange
timeFrame: Day 0, end of session
measure: Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange
timeFrame: Day 0, end of session
measure: Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, 1 hour after the session
measure: Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, 1 hour after the session
measure: Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, 4 hours after the session
measure: Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, 4 hours after the session
measure: Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
timeFrame: Month 1, Day 1, 1 hour after the session
measure: Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
timeFrame: Month 1, Day 1, 1 hour after the session
measure: Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
timeFrame: Month 1, Day 4, 4 hours after the session
measure: Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
timeFrame: Month 1, Day 4, 4 hours after the session
measure: Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
timeFrame: Month 1, Day 3
measure: Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
timeFrame: Month 1, Day 3
measure: Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, before the session
measure: Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, before the session
measure: Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, end of session
measure: Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, end of session
measure: Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, 1 hour after the session
measure: Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, 1 hour after the session
measure: Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, 4 hours after the session
measure: Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 0, 4 hours after the session
measure: Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 1
measure: Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 1
measure: Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 3
measure: Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
timeFrame: Day 3
measure: Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
timeFrame: Month 1, Day 1, 1 hour after the session
measure: Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
timeFrame: Month 1, Day 1, 1 hour after the session
measure: Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
timeFrame: Month 1, Day 1, 4 hours after the session
measure: Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
timeFrame: Month 1, Day 1, 4 hours after the session
measure: Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
timeFrame: Month 1, Day 3
measure: Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
timeFrame: Month 1, Day 3
Secondary outcomes:
measure: Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Platelets
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Basophils
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
timeFrame: Day 4
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
timeFrame: Day 3
measure: Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 0, Hour 0
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 0, Hour 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 0, Hour 4
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 1
measure: Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 3
measure: Serum albumin before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: Serum albumin after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: Serum albumin after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: Serum albumin after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Serum albumin after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Factors VIII, IX, XI and XII before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Platelet function test before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: Platelet function test after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: Platelet function test after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: Platelet function test after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Platelet function test after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 0, Hour 0
measure: Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 0, Hour 1
measure: Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 0, Hour 4
measure: Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 1
measure: Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 3
measure: Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 0
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 1
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
timeFrame: Day 0, Hour 4
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
timeFrame: Day 1
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : White blood cells
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : White blood cells
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : White blood cells
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : White blood cells
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : White blood cells
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Red blood cells
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Red blood cells
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Red blood cells
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Red blood cells
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Red blood cells
timeFrame: Day 4
measure: Complete blood count before the double filtration plasmapheresis session : Hemoglobin
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Hemoglobin
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Hemoglobin
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Hemoglobin
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Hemoglobin
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Platelets
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Platelets
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Platelets
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Platelets
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Platelets
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Neutrophils
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Neutrophils
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Neutrophils
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Neutrophils
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Neutrophils
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Lymphocytes
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Lymphocytes
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Lymphocytes
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Lymphocytes
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Lymphocytes
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Monocytes
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Monocytes
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Monocytes
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Monocytes
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Monocytes
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Eosinophils
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Eosinophils
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Eosinophils
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Eosinophils
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Eosinophils
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Basophils
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Basophils
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Basophils
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Basophils
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Basophils
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Hematocrit
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Hematocrit
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Hematocrit
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Hematocrit
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Hematocrit
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
timeFrame: Day 3
measure: Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 0, Hour 0
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 0, Hour 1
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 0, Hour 4
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 1
measure: Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
timeFrame: Day 3
measure: Serum albumin before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: Serum albumin after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: Serum albumin after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: Serum albumin after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: Serum albumin after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: Factors VIII, IX, XI and XII before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: Platelet function test before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: Platelet function test after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: Platelet function test after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: Platelet function test after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: Platelet function test after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 0
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 1
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
timeFrame: Day 0, Hour 4
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
timeFrame: Day 1
measure: von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
timeFrame: Day 3
measure: Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 0, Hour 0
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 0, Hour 1
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 0, Hour 4
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 1
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
timeFrame: Day 3
measure: Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (thrombotic exploration version)
timeFrame: Day 0, Hour 0
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
timeFrame: Day 0, Hour 1
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
timeFrame: Day 0, Hour 4
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
timeFrame: Day 1
measure: Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)
timeFrame: Day 3
measure: Plasma Bank
timeFrame: Before Day 0, hour 0
measure: Plasma Bank
timeFrame: Day 0, hour1
measure: Plasma Bank
timeFrame: Day 0, hour 4
measure: Plasma Bank
timeFrame: Day 1
measure: Plasma Bank
timeFrame: Day 3
measure: Plasma Bank
timeFrame: After end of session Day 0, H0
Other outcomes:
measure: Gender of patients
timeFrame: Day 0, Hour 0
measure: Age of patients
timeFrame: Day 0, Hour 0
measure: Weight of patients
timeFrame: Day 0, Hour 0
measure: Height of patients
timeFrame: Day 0, Hour 0
measure: Diagnostic history of patients
timeFrame: Day 0, Hour 0
measure: Patient's apheresis protocol
timeFrame: Day 0, Hour 0
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Nîmes University Hospital
name: Emilie PAMBRUN, Docteur
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital
name: Sylvie BOUVIER, Docteur
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital
name: Jean-Christophe GRIS, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nîmes University Hospital
name: Mathieu FORTIER
role: PRINCIPAL_INVESTIGATOR
References: