An interventional study of Single Plasma Exchange followed by Double Filtration Plasmapheresis in Hyperfibrinogenemia and Hemostatic Disorder, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Health services research
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.
361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.
This study's planned enrollment of 6 is below the median of 60 across 171 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis
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.
Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis
Double Filtration Plasmapheresis followed by Single Plasma Exchange
Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: Day 0, before the session
Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Time frame: Day 0, before the session
Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: Day 0, end of session
Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Time frame: Day 0, end of session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: 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®.
Time frame: Day 0, 1 hour after the session
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: 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®.
Time frame: Day 0, 4 hours after the session
Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: Day 1
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Time frame: Day 1
Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: Day 3
Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Time frame: Day 3
Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange
Clauss functional method, g/L
Time frame: 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®.
Time frame: 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
Time frame: 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®.
Time frame: 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
Time frame: Month 1, Day 3
Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange
Automated thrombin generation test on Génésia®.
Time frame: Month 1, Day 3
Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis
Clauss functional method, g/L
Time frame: 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®.
Time frame: Day 0, before the session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
Clauss functional method, g/L
Time frame: 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®.
Time frame: Day 0, end of session
Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis
Clauss functional method, g/L
Time frame: 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®.
Time frame: 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
Time frame: 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®.
Time frame: Day 0, 4 hours after the session
Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
Clauss functional method, g/L
Time frame: Day 1
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
Automated thrombin generation test on Génésia®.
Time frame: Day 1
Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis
Clauss functional method, g/L
Time frame: Day 3
Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis
Automated thrombin generation test on Génésia®.
Time frame: Day 3
Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis
Clauss functional method, g/L
Time frame: 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®.
Time frame: 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
Time frame: 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®.
Time frame: 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
Time frame: Month 1, Day 3
Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis
Automated thrombin generation test on Génésia®.
Time frame: Month 1, Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin
Quantitative, grams per liter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Quantitative, grams per liter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Quantitative, grams per liter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Quantitative, grams per liter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin
Quantitative, grams per liter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Platelets
Quantitative, %
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Quantitative, %
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Quantitative, %
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Quantitative, %
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Platelets
Quantitative, %
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Basophils
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Basophils
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit
Quantitative, %
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Quantitative, %
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Quantitative, %
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Quantitative, %
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit
Quantitative, %
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Quantitative, %
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Quantitative, %
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Quantitative, %
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Quantitative, %
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume
Quantitative, %
Time frame: Day 4
Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Quantitative, in pg
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Quantitative, in pg
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Quantitative, in pg
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Quantitative, in pg
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin
Quantitative, in pg
Time frame: Day 3
Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Quantitative, in g/L
Time frame: Day 0, Hour 0
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Quantitative, in g/L
Time frame: Day 0, Hour 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Quantitative, in g/L
Time frame: Day 0, Hour 4
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Quantitative, in g/L
Time frame: Day 1
Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration
Quantitative, in g/L
Time frame: Day 3
Serum albumin before the plasmapheresis session with single plasma exchange
Quantitative, in g/dL
Time frame: Day 0, Hour 0
Serum albumin after the plasmapheresis session with single plasma exchange
Quantitative, in g/dL
Time frame: Day 0, Hour 1
Serum albumin after the plasmapheresis session with single plasma exchange
Quantitative, in g/dL
Time frame: Day 0, Hour 4
Serum albumin after the plasmapheresis session with single plasma exchange
Quantitative, in g/dL
Time frame: Day 1
Serum albumin after the plasmapheresis session with single plasma exchange
Quantitative, in g/dL
Time frame: Day 3
Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange
In seconds
Time frame: Day 0, Hour 0
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
In seconds
Time frame: Day 0, Hour 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
In seconds
Time frame: Day 0, Hour 4
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
In seconds
Time frame: Day 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange
In seconds
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 3
Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange
Prothrombin assay, in seconds
Time frame: Day 0, Hour 0
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Prothrombin assay, in seconds
Time frame: Day 0, Hour 1
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Prothrombin assay, in seconds
Time frame: Day 0, Hour 4
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Prothrombin assay, in seconds
Time frame: Day 1
Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange
Prothrombin assay, in seconds
Time frame: Day 3
D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1
D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 3
Platelet function test before the plasmapheresis session with single plasma exchange
ADP/collagen and adrenalin/collagen cartridges.
Time frame: Day 0, Hour 0
Platelet function test after the plasmapheresis session with single plasma exchange
ADP/collagen and adrenalin/collagen cartridges.
Time frame: Day 0, Hour 1
Platelet function test after the plasmapheresis session with single plasma exchange
ADP/collagen and adrenalin/collagen cartridges.
Time frame: Day 0, Hour 4
Platelet function test after the plasmapheresis session with single plasma exchange
ADP/collagen and adrenalin/collagen cartridges.
Time frame: Day 1
Platelet function test after the plasmapheresis session with single plasma exchange
ADP/collagen and adrenalin/collagen cartridges.
Time frame: Day 3
von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange
Binding to platelet membrane glycoprotein Ib
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange
Binding to platelet membrane glycoprotein Ib
Time frame: Day 3
Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Triggered by 1 pM tissue factor
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1
Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)
Triggered by 1 pM tissue factor
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : White blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : White blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : White blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : White blood cells
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : White blood cells
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Red blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Red blood cells
Quantitative, per microliter
Time frame: Day 4
Complete blood count before the double filtration plasmapheresis session : Hemoglobin
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Hemoglobin
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Platelets
Quantitative, %
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Platelets
Quantitative, %
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Platelets
Quantitative, %
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Platelets
Quantitative, %
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Platelets
Quantitative, %
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Neutrophils
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Neutrophils
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Lymphocytes
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Lymphocytes
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Monocytes
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Monocytes
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Monocytes
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Monocytes
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Monocytes
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Eosinophils
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Eosinophils
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Basophils
Quantitative, per microliter
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Basophils
Quantitative, per microliter
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Basophils
Quantitative, per microliter
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Basophils
Quantitative, per microliter
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Basophils
Quantitative, per microliter
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Hematocrit
Quantitative, %
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Quantitative, %
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Quantitative, %
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Quantitative, %
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Hematocrit
Quantitative, %
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume
Quantitative, fL
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Quantitative, fL
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Quantitative, fL
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Quantitative, fL
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume
Quantitative, fL
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Quantitative, pg
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Quantitative, pg
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Quantitative, pg
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Quantitative, pg
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin
Quantitative, pg
Time frame: Day 3
Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Quantitative, g/L
Time frame: Day 0, Hour 0
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Quantitative, g/L
Time frame: Day 0, Hour 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Quantitative, g/L
Time frame: Day 0, Hour 4
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Quantitative, g/L
Time frame: Day 1
Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration
Quantitative, g/L
Time frame: Day 3
Serum albumin before the double filtration plasmapheresis session.
Quantitative, g/L
Time frame: Day 0, Hour 0
Serum albumin after the double filtration plasmapheresis session.
Quantitative, g/L
Time frame: Day 0, Hour 1
Serum albumin after the double filtration plasmapheresis session.
Quantitative, g/L
Time frame: Day 0, Hour 4
Serum albumin after the double filtration plasmapheresis session.
Quantitative, g/L
Time frame: Day 1
Serum albumin after the double filtration plasmapheresis session.
Quantitative, g/L
Time frame: Day 3
Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session.
In seconds
Time frame: Day 0, Hour 0
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
In seconds
Time frame: Day 0, Hour 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
In seconds
Time frame: Day 0, Hour 4
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
In seconds
Time frame: Day 1
Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.
In seconds
Time frame: Day 3
Factors VIII, IX, XI and XII before the double filtration plasmapheresis session.
1-stage APTT-based Factor assay
Time frame: Day 0, Hour 0
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
1-stage APTT-based Factor assay
Time frame: Day 0, Hour 1
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
1-stage APTT-based Factor assay
Time frame: Day 0, Hour 4
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
1-stage APTT-based Factor assay
Time frame: Day 1
Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.
1-stage APTT-based Factor assay
Time frame: Day 3
Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session.
Prothrombin assay, in seconds
Time frame: Day 0, Hour 0
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Prothrombin assay, in seconds
Time frame: Day 0, Hour 1
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Prothrombin assay, in seconds
Time frame: Day 0, Hour 4
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Prothrombin assay, in seconds
Time frame: Day 1
Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.
Prothrombin assay, in seconds
Time frame: Day 3
D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session.
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 0, Hour 0
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 0, Hour 1
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 0, Hour 4
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 1
D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.
By enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 3
Platelet function test before the double filtration plasmapheresis session.
ADP/collagen and adrenalin/collagen cartridges
Time frame: Day 0, Hour 0
Platelet function test after the double filtration plasmapheresis session.
ADP/collagen and adrenalin/collagen cartridges
Time frame: Day 0, Hour 1
Platelet function test after the double filtration plasmapheresis session.
ADP/collagen and adrenalin/collagen cartridges
Time frame: Day 0, Hour 4
Platelet function test after the double filtration plasmapheresis session.
ADP/collagen and adrenalin/collagen cartridges
Time frame: Day 1
Platelet function test after the double filtration plasmapheresis session.
ADP/collagen and adrenalin/collagen cartridges
Time frame: Day 3
von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session.
Binding to platelet membrane glycoprotein Ib
Time frame: Day 0, Hour 0
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Binding to platelet membrane glycoprotein Ib
Time frame: Day 0, Hour 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Binding to platelet membrane glycoprotein Ib
Time frame: Day 0, Hour 4
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Binding to platelet membrane glycoprotein Ib
Time frame: Day 1
von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.
Binding to platelet membrane glycoprotein Ib
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 3
Plasma Bank
Storage of unused tube ends
Time frame: Before Day 0, hour 0
Plasma Bank
Storage of unused tube ends
Time frame: Day 0, hour1
Plasma Bank
Storage of unused tube ends
Time frame: Day 0, hour 4
Plasma Bank
Storage of unused tube ends
Time frame: Day 1
Plasma Bank
Storage of unused tube ends
Time frame: Day 3
Plasma Bank
Storage of unused tube ends
Time frame: After end of session Day 0, H0
Gender of patients
Recorded as Male, Female, Nonbinary
Time frame: Day 0, Hour 0
Age of patients
Recorded in years
Time frame: Day 0, Hour 0
Weight of patients
Recorded in kilos
Time frame: Day 0, Hour 0
Height of patients
Recorded in centimeters
Time frame: Day 0, Hour 0
Diagnostic history of patients
The patients' diagnostic history will be recorded
Time frame: Day 0, Hour 0
Patient's apheresis protocol
The apheresis protocol used, and parameters related to plasmapheresis will be recorded
Time frame: Day 0, Hour 0
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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