Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage

NCT ID: NCT06473233

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2025-03-06

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 2g/L 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).

Conditions

Postpartum Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Before TEG6S

Patients managed in a period of 12 months before the implementation of TEG6S®

No interventions assigned to this group

After TEG6S

Patients managed in a period of 12 months after the implementation of TEG6S®

TEG6S

Intervention Type: DEVICE

Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician

Interventions

TEG6S

Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Woman of 18 years old or more
• Delivery at the level III maternity of Centre Hospitalier Sud Francilien (CHSF) (Corbeil-Essonnes, France) between 2022 and 2024, except deliveries during cyber-attack period at CHSF (from August 2022 to December 2022 included), due to uncertainty over the completeness of the data.
• Presenting postpartum hemorrhage with estimated blood loss of 1000mL or more
• No constitutional hemostasis anomaly
• No treatment interfering with hemostasis
• No use of blood products and/or pro-coagulant products before delivery

Exclusion Criteria

• Patient informed of the research and refusing the use of the data

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fatima BRIK

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, France

Countries

France

Other Identifiers

2024/0013

Identifier Type: -

Identifier Source: org_study_id