Clinical trial NCT06473233: Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
Official title: Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women who gave birth at the level III maternity of Centre Hospitalier Sud Francilien and had postpartum haemorrhage greater than 1000mL or more.

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).

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

Primary outcomes:
measure: Fibrinogen consumption
timeFrame: up to 24 hours
Secondary outcomes:
measure: Total number of TEG6S®
timeFrame: at 12 months
measure: Estimated blood loss
timeFrame: up to 24 hours
measure: Calculated blood loss
timeFrame: up to 24 hours
measure: Consumption of packed red blood cells (RBC)
timeFrame: up to 24 hours
measure: Consumption of fresh frozen plasma (FFP)
timeFrame: up to 24 hours
measure: Invasive haemostatic procedure
timeFrame: up to 24 hours
measure: Maternal death
timeFrame: until leaving the hospital
measure: ICU admission
timeFrame: until leaving the hospital
measure: ICU length of stay
timeFrame: until discharge from the intensive care unit
measure: Total length of stay
timeFrame: until discharge from the intensive care unit
measure: Acute anemia
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Fatima BRIK
role: PRINCIPAL_INVESTIGATOR
References: