Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-12
Brief Title:
Interest of TEG6S in Reducing Transfusion Needs During Postpartum Haemorrhage
Sponsor:
Centre Hospitalier Sud Francilien
Organization:
Centre Hospitalier Sud Francilien
Study Overview
Official Title:
Interest of TEG6S in Reducing Transfusion Needs During Postpartum Haemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTEGRAL-HPP
Brief Summary:
The main objective of this study is to evaluate fibrinogen consumption transfusion need and other security outcomes in women with postpartum hemorrhage of 1000 mL or more before and after the implementation of a TEG6S device at a level III maternity unit Centre Hospitalier Sud Francilien Corbeil-Essonnes France
Detailed Description:
Acquired obstetrical coagulopathy during massive postpartum hemorrhage PPH is a serious and frequent complication of delivery It has been shown that fibrinogen levels are the first to fall during PPH and that a level inferior to a threshold of 2gL is strongly associated with progression to severe PPH hemostatic impairment transfusion and invasive hemostatic procedures
The clinical diagnosis of coagulopathy is difficult and the biological diagnosis by usual laboratory tests is often delayed leading to the empirical administration of fibrinogen and blood products sometimes unnecessary
The TEG6S is a viscoelastic testing device performed on whole blood which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes
The anomalies detected by the TEG6S allow for the early diagnosis of acquired coagulopathy especially hypofibrinogenemia Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits in addition to improving patient prognosis through early and appropriate treatment including the absence of early blind treatment in the absence of coagulopathy
The clinical diagnosis of coagulopathy is difficult and the biological diagnosis by usual laboratory tests is often delayed leading to the empirical administration of fibrinogen and blood products sometimes unnecessary
The TEG6S is a viscoelastic testing device performed on whole blood which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes
The anomalies detected by the TEG6S allow for the early diagnosis of acquired coagulopathy especially hypofibrinogenemia Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits in addition to improving patient prognosis through early and appropriate treatment including the absence of early blind treatment in the absence of coagulopathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None