Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
时间窗: Day 3
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
时间窗: Month 1, Day 3
Clauss functional method, g/L
Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
时间窗: Month 1, Day 3
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange
时间窗: Day 0, before the session
Clauss functional method, g/L
Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange
时间窗: Day 0, before the session
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange
时间窗: Day 0, end of session
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
时间窗: Month 1, Day 3
Clauss functional method, g/L
Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
时间窗: Day 3
Clauss functional method, g/L
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
时间窗: Day 3
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange
时间窗: Day 0, end of session
Clauss functional method, g/L
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
时间窗: Month 1, Day 3
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis
时间窗: Day 0, before the session
Clauss functional method, g/L
Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis
时间窗: Day 0, before the session
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
时间窗: Day 0, 4 hours after the session
Clauss functional method, g/L
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis
时间窗: Day 0, 4 hours after the session
Automated thrombin generation test on Génésia®.
Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
时间窗: Day 3
Clauss functional method, g/L
次要结局
- D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Platelets(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Platelets(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes(Day 3)
- Platelet function test before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Basophils(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Basophils(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume(Day 4)
- Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin(Day 3)
- Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration(Day 0, Hour 0)
- Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration(Day 3)
- Serum albumin before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Serum albumin after the plasmapheresis session with single plasma exchange(Day 3)
- Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange(Day 3)
- Factors VIII, IX, XI and XII before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange(Day 3)
- Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange(Day 3)
- D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Platelet function test after the plasmapheresis session with single plasma exchange(Day 3)
- von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange(Day 3)
- Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)(Day 0, Hour 0)
- Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)(Day 3)
- Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange(Day 0, Hour 0)
- Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange(Day 3)
- Complete blood count before the double filtration plasmapheresis session : White blood cells(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : White blood cells(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Red blood cells(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Red blood cells(Day 4)
- Complete blood count before the double filtration plasmapheresis session : Hemoglobin(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Hemoglobin(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Platelets(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Platelets(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Neutrophils(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Neutrophils(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Lymphocytes(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Lymphocytes(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Monocytes(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Monocytes(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Eosinophils(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Eosinophils(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Basophils(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Basophils(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Hematocrit(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Hematocrit(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin(Day 3)
- Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration(Day 0, Hour 0)
- Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration(Day 3)
- Serum albumin before the double filtration plasmapheresis session.(Day 0, Hour 0)
- Serum albumin after the double filtration plasmapheresis session.(Day 3)
- Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session.(Day 0, Hour 0)
- Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.(Day 3)
- Factors VIII, IX, XI and XII before the double filtration plasmapheresis session.(Day 0, Hour 0)
- Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.(Day 3)
- Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session.(Day 0, Hour 0)
- Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.(Day 3)
- D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session.(Day 0, Hour 0)
- D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.(Day 3)
- Platelet function test before the double filtration plasmapheresis session.(Day 0, Hour 0)
- Platelet function test after the double filtration plasmapheresis session.(Day 3)
- von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session.(Day 0, Hour 0)
- von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.(Day 3)
- Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)(Day 0, Hour 0)
- Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)(Day 3)
- Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (thrombotic exploration version)(Day 0, Hour 0)
- Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)(Day 3)
- Plasma Bank(After end of session Day 0, H0)