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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients benefitting from Single Plasma Exchange followed by Double Filtration Plasmapheresis | Active Comparator | For the patients in this group, the first cycle (T1) will consist of Single Plasma Exchange and the second cycle (T2) of Double Filtration Plasmapheresis. |
|
| Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma Exchange | Active Comparator | For the patients in this group, the first cycle (T1) will consist of Double Filtration Plasmapheresis and the second cycle (T2) of Single Plasma Exchange. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Plasma Exchange followed by Double Filtration Plasmapheresis | Procedure | Double Filtration Plasmapheresis followed by Single Plasma Exchange |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Day 0, before the session |
| Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Day 0, before the session |
| Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Day 0, end of session |
| Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Day 0, end of session |
| Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Day 0, 1 hour after the session |
| Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Day 0, 1 hour after the session |
| Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange | Clauss functional method, g/L |
| Measure | Description | Time Frame |
|---|---|---|
| Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells |
| Measure | Description | Time Frame |
|---|---|---|
| Gender of patients | Recorded as Male, Female, Nonbinary | Day 0, Hour 0 |
| Age of patients | Recorded in years | Day 0, Hour 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier MORANNE, Professor | Contact | +334.66.68.31.49 | olivier.moranne@chu-nimes.fr | |
| Anissa MEGZARI | Contact | +33466684236 | drc@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie PAMBRUN, Docteur | Nîmes University Hospital | Principal Investigator |
| Sylvie BOUVIER, Docteur | Nîmes University Hospital | Principal Investigator |
| Jean-Christophe GRIS, Professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
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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.
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| Day 0, 4 hours after the session |
| Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Day 0, 4 hours after the session |
| Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Day 1 |
| Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Day 1 |
| Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Day 3 |
| Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Day 3 |
| Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Month 1, Day 1, 1 hour after the session |
| Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Month 1, Day 1, 1 hour after the session |
| Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Month 1, Day 4, 4 hours after the session |
| Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Month 1, Day 4, 4 hours after the session |
| Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange | Clauss functional method, g/L | Month 1, Day 3 |
| Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange | Automated thrombin generation test on Génésia®. | Month 1, Day 3 |
| Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Day 0, before the session |
| Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Day 0, before the session |
| Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Day 0, end of session |
| Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Day 0, end of session |
| Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Day 0, 1 hour after the session |
| Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Day 0, 1 hour after the session |
| Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Day 0, 4 hours after the session |
| Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Day 0, 4 hours after the session |
| Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Day 1 |
| Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Day 1 |
| Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Day 3 |
| Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Day 3 |
| Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Month 1, Day 1, 1 hour after the session |
| Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Month 1, Day 1, 1 hour after the session |
| Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Month 1, Day 1, 4 hours after the session |
| Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Month 1, Day 1, 4 hours after the session |
| Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis | Clauss functional method, g/L | Month 1, Day 3 |
| Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis | Automated thrombin generation test on Génésia®. | Month 1, Day 3 |
Quantitative, per microliter
| Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin | Quantitative, grams per liter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin | Quantitative, grams per liter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin | Quantitative, grams per liter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin | Quantitative, grams per liter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin | Quantitative, grams per liter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Platelets | Quantitative, % | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Platelets | Quantitative, % | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Platelets | Quantitative, % | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Platelets | Quantitative, % | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Platelets | Quantitative, % | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Basophils | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Basophils | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Basophils | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Basophils | Quantitative, per microliter | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Basophils | Quantitative, per microliter | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit | Quantitative, % | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit | Quantitative, % | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit | Quantitative, % | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit | Quantitative, % | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit | Quantitative, % | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume | Quantitative, % | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume | Quantitative, % | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume | Quantitative, % | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume | Quantitative, % | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume | Quantitative, % | Day 4 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin | Quantitative, in pg | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin | Quantitative, in pg | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin | Quantitative, in pg | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin | Quantitative, in pg | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin | Quantitative, in pg | Day 3 |
| Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration | Quantitative, in g/L | Day 0, Hour 0 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration | Quantitative, in g/L | Day 0, Hour 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration | Quantitative, in g/L | Day 0, Hour 4 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration | Quantitative, in g/L | Day 1 |
| Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration | Quantitative, in g/L | Day 3 |
| Serum albumin before the plasmapheresis session with single plasma exchange | Quantitative, in g/dL | Day 0, Hour 0 |
| Serum albumin after the plasmapheresis session with single plasma exchange | Quantitative, in g/dL | Day 0, Hour 1 |
| Serum albumin after the plasmapheresis session with single plasma exchange | Quantitative, in g/dL | Day 0, Hour 4 |
| Serum albumin after the plasmapheresis session with single plasma exchange | Quantitative, in g/dL | Day 1 |
| Serum albumin after the plasmapheresis session with single plasma exchange | Quantitative, in g/dL | Day 3 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange | In seconds | Day 0, Hour 0 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange | In seconds | Day 0, Hour 1 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange | In seconds | Day 0, Hour 4 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange | In seconds | Day 1 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange | In seconds | Day 3 |
| Factors VIII, IX, XI and XII before the plasmapheresis session with single plasma exchange | By 1-stage APTT-based Factor assay, in seconds | Day 0, Hour 0 |
| Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange | By 1-stage APTT-based Factor assay, in seconds | Day 0, Hour 1 |
| Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange | By 1-stage APTT-based Factor assay, in seconds | Day 0, Hour 4 |
| Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange | By 1-stage APTT-based Factor assay, in seconds | Day 1 |
| Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange | By 1-stage APTT-based Factor assay, in seconds | Day 3 |
| Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange | Prothrombin assay, in seconds | Day 0, Hour 0 |
| Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange | Prothrombin assay, in seconds | Day 0, Hour 1 |
| Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange | Prothrombin assay, in seconds | Day 0, Hour 4 |
| Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange | Prothrombin assay, in seconds | Day 1 |
| Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange | Prothrombin assay, in seconds | Day 3 |
| D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange | By enzyme-linked immunosorbent assay (ELISA) method | Day 0, Hour 0 |
| D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange | By enzyme-linked immunosorbent assay (ELISA) method | Day 0, Hour 1 |
| D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange | By enzyme-linked immunosorbent assay (ELISA) method | Day 0, Hour 4 |
| D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange | By enzyme-linked immunosorbent assay (ELISA) method | Day 1 |
| D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange | By enzyme-linked immunosorbent assay (ELISA) method | Day 3 |
| Platelet function test before the plasmapheresis session with single plasma exchange | ADP/collagen and adrenalin/collagen cartridges. | Day 0, Hour 0 |
| Platelet function test after the plasmapheresis session with single plasma exchange | ADP/collagen and adrenalin/collagen cartridges. | Day 0, Hour 1 |
| Platelet function test after the plasmapheresis session with single plasma exchange | ADP/collagen and adrenalin/collagen cartridges. | Day 0, Hour 4 |
| Platelet function test after the plasmapheresis session with single plasma exchange | ADP/collagen and adrenalin/collagen cartridges. | Day 1 |
| Platelet function test after the plasmapheresis session with single plasma exchange | ADP/collagen and adrenalin/collagen cartridges. | Day 3 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange | Binding to platelet membrane glycoprotein Ib | Day 0, Hour 0 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange | Binding to platelet membrane glycoprotein Ib | Day 0, Hour 1 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange | Binding to platelet membrane glycoprotein Ib | Day 0, Hour 4 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange | Binding to platelet membrane glycoprotein Ib | Day 1 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange | Binding to platelet membrane glycoprotein Ib | Day 3 |
| Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 0, Hour 0 |
| Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 0, Hour 1 |
| Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 0, Hour 4 |
| Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 1 |
| Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 3 |
| Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange | Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version) | Day 0, Hour 0 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange | Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version) | Day 0, Hour 1 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange | Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version) | Day 0, Hour 4 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange | Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version) | Day 1 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange | Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version) | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : White blood cells | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : White blood cells | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : White blood cells | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : White blood cells | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : White blood cells | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Red blood cells | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Red blood cells | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Red blood cells | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Red blood cells | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Red blood cells | Quantitative, per microliter | Day 4 |
| Complete blood count before the double filtration plasmapheresis session : Hemoglobin | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Hemoglobin | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Hemoglobin | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Hemoglobin | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Hemoglobin | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Platelets | Quantitative, % | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Platelets | Quantitative, % | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Platelets | Quantitative, % | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Platelets | Quantitative, % | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Platelets | Quantitative, % | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Neutrophils | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Neutrophils | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Neutrophils | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Neutrophils | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Neutrophils | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Lymphocytes | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Lymphocytes | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Lymphocytes | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Lymphocytes | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Lymphocytes | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Monocytes | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Monocytes | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Monocytes | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Monocytes | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Monocytes | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Eosinophils | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Eosinophils | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Eosinophils | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Eosinophils | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Eosinophils | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Basophils | Quantitative, per microliter | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Basophils | Quantitative, per microliter | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Basophils | Quantitative, per microliter | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Basophils | Quantitative, per microliter | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Basophils | Quantitative, per microliter | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Hematocrit | Quantitative, % | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Hematocrit | Quantitative, % | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Hematocrit | Quantitative, % | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Hematocrit | Quantitative, % | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Hematocrit | Quantitative, % | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume | Quantitative, fL | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume | Quantitative, fL | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume | Quantitative, fL | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume | Quantitative, fL | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume | Quantitative, fL | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin | Quantitative, pg | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin | Quantitative, pg | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin | Quantitative, pg | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin | Quantitative, pg | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin | Quantitative, pg | Day 3 |
| Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration | Quantitative, g/L | Day 0, Hour 0 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration | Quantitative, g/L | Day 0, Hour 1 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration | Quantitative, g/L | Day 0, Hour 4 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration | Quantitative, g/L | Day 1 |
| Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration | Quantitative, g/L | Day 3 |
| Serum albumin before the double filtration plasmapheresis session. | Quantitative, g/L | Day 0, Hour 0 |
| Serum albumin after the double filtration plasmapheresis session. | Quantitative, g/L | Day 0, Hour 1 |
| Serum albumin after the double filtration plasmapheresis session. | Quantitative, g/L | Day 0, Hour 4 |
| Serum albumin after the double filtration plasmapheresis session. | Quantitative, g/L | Day 1 |
| Serum albumin after the double filtration plasmapheresis session. | Quantitative, g/L | Day 3 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session. | In seconds | Day 0, Hour 0 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session. | In seconds | Day 0, Hour 1 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session. | In seconds | Day 0, Hour 4 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session. | In seconds | Day 1 |
| Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session. | In seconds | Day 3 |
| Factors VIII, IX, XI and XII before the double filtration plasmapheresis session. | 1-stage APTT-based Factor assay | Day 0, Hour 0 |
| Factors VIII, IX, XI and XII after the double filtration plasmapheresis session. | 1-stage APTT-based Factor assay | Day 0, Hour 1 |
| Factors VIII, IX, XI and XII after the double filtration plasmapheresis session. | 1-stage APTT-based Factor assay | Day 0, Hour 4 |
| Factors VIII, IX, XI and XII after the double filtration plasmapheresis session. | 1-stage APTT-based Factor assay | Day 1 |
| Factors VIII, IX, XI and XII after the double filtration plasmapheresis session. | 1-stage APTT-based Factor assay | Day 3 |
| Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session. | Prothrombin assay, in seconds | Day 0, Hour 0 |
| Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session. | Prothrombin assay, in seconds | Day 0, Hour 1 |
| Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session. | Prothrombin assay, in seconds | Day 0, Hour 4 |
| Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session. | Prothrombin assay, in seconds | Day 1 |
| Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session. | Prothrombin assay, in seconds | Day 3 |
| D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session. | By enzyme-linked immunosorbent assay (ELISA) method | Day 0, Hour 0 |
| D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session. | By enzyme-linked immunosorbent assay (ELISA) method | Day 0, Hour 1 |
| D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session. | By enzyme-linked immunosorbent assay (ELISA) method | Day 0, Hour 4 |
| D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session. | By enzyme-linked immunosorbent assay (ELISA) method | Day 1 |
| D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session. | By enzyme-linked immunosorbent assay (ELISA) method | Day 3 |
| Platelet function test before the double filtration plasmapheresis session. | ADP/collagen and adrenalin/collagen cartridges | Day 0, Hour 0 |
| Platelet function test after the double filtration plasmapheresis session. | ADP/collagen and adrenalin/collagen cartridges | Day 0, Hour 1 |
| Platelet function test after the double filtration plasmapheresis session. | ADP/collagen and adrenalin/collagen cartridges | Day 0, Hour 4 |
| Platelet function test after the double filtration plasmapheresis session. | ADP/collagen and adrenalin/collagen cartridges | Day 1 |
| Platelet function test after the double filtration plasmapheresis session. | ADP/collagen and adrenalin/collagen cartridges | Day 3 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session. | Binding to platelet membrane glycoprotein Ib | Day 0, Hour 0 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session. | Binding to platelet membrane glycoprotein Ib | Day 0, Hour 1 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session. | Binding to platelet membrane glycoprotein Ib | Day 0, Hour 4 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session. | Binding to platelet membrane glycoprotein Ib | Day 1 |
| von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session. | Binding to platelet membrane glycoprotein Ib | Day 3 |
| Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 0, Hour 0 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 0, Hour 1 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 0, Hour 4 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 1 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version) | Triggered by 1 pM tissue factor | Day 3 |
| Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (thrombotic exploration version) | Triggered by 5 pM tissue factor with response to purified thrombomodulin | Day 0, Hour 0 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version) | Triggered by 5 pM tissue factor with response to purified thrombomodulin | Day 0, Hour 1 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version) | Triggered by 5 pM tissue factor with response to purified thrombomodulin | Day 0, Hour 4 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version) | Triggered by 5 pM tissue factor with response to purified thrombomodulin | Day 1 |
| Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version) | Triggered by 5 pM tissue factor with response to purified thrombomodulin | Day 3 |
| Plasma Bank | Storage of unused tube ends | Before Day 0, hour 0 |
| Plasma Bank | Storage of unused tube ends | Day 0, hour1 |
| Plasma Bank | Storage of unused tube ends | Day 0, hour 4 |
| Plasma Bank | Storage of unused tube ends | Day 1 |
| Plasma Bank | Storage of unused tube ends | Day 3 |
| Plasma Bank | Storage of unused tube ends | After end of session Day 0, H0 |
| Weight of patients | Recorded in kilos | Day 0, Hour 0 |
| Height of patients | Recorded in centimeters | Day 0, Hour 0 |
| Diagnostic history of patients | The patients' diagnostic history will be recorded | Day 0, Hour 0 |
| Patient's apheresis protocol | The apheresis protocol used, and parameters related to plasmapheresis will be recorded | Day 0, Hour 0 |
| Nîmes University Hospital |
| Principal Investigator |
| Mathieu FORTIER | Nîmes University Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided