Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571552
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Coagulation Disorders Secondary to Two Plasmapheresis Techniques Double Filtration Plasmapheresis vs PFS Descriptive Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques Double Filtration Plasmapheresis vs PFS Descriptive Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APHERCOAG
Brief Summary:
Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session with little data documenting the kinetics of regeneration of these factors It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding However the methods of correcting these disorders are debatable Finally it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected Haemostasis is probably not based solely on the level of blood fibrinogen but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session according to session type and fibrinogen level at the end of the session The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity post therapeutic plasmapheresis will enable us to better assess the risk of haemorrhage and propose preventive measures
Detailed Description:
Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved Some data are available on changes in circulating haemostasis factors with the Single Plasma Exchange technique and the Double Filtration Plasmapheresis however most often these studies are carried out in specific clinical situations where other haemostasis disorders may be present such as severe renal failure Furthermore in these studies assessment of changes in haemostasis is often limited to coagulation factor assays before and after the session with little data documenting the kinetics of regeneration of these factors whose molecular weight and half-life vary widely To date there is no clear consensusrecommendation 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 bleedingThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None