Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-12-05
Brief Title:
Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabsFIB Analyzer and Its Measurement by Conventional Method Clauss Fibrinogen in the Context of Severe Postpartum Haemorrhage
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabsFIB Analyzer and Its Measurement by Conventional Method Clauss Fibrinogen in the Context of Severe Postpartum Haemorrhage a Prospective Multicenter Non-interventional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
FIB-HPPS
Brief Summary:
In France in 2021 116 of deliveries were complicated by a postpartum haemorrhage PPH including 30 by severe PPH the bleeding volume exceeds 1000 ml Severe PPH is the 5th cause of maternal death 84 or 12 deaths per 100000 live births These deaths were considered preventable in 90 of cases A plasma fibrinogen concentration below 2 gL is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH Measuring the concentration of fibrinogen using a rapid test simple to perform and interpret available in the delivery room could optimize the management of severe PPH The qLabsFIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patients bedside could meet this objective
Detailed Description:
In France in 2021 116 of deliveries were complicated by postpartum hemorrhage PPH including 30 by severe PPH the bleeding volume exceeds 1000 ml Severe PPH is the 5th cause of maternal death 84 or 12 deaths per 100000 live births These deaths were considered preventable in 90 of cases A plasma fibrinogen concentration below 2 gL is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH Measuring the concentration of fibrinogen using a rapid test simple to perform and interpret available in the delivery room could optimize the management of severe PPH The qLabsFIB analyzer distributed by Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patients bedside could meet this objective
The hypothesis of the study is a concordance between the measurement of fibrinogen by the qLabsFIB Monitoring system and by the Clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level 2 gL
The prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration 2g predictive of an unfavorable evolution in the context of severe PPH
The hypothesis of the study is a concordance between the measurement of fibrinogen by the qLabsFIB Monitoring system and by the Clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level 2 gL
The prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration 2g predictive of an unfavorable evolution in the context of severe PPH
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