Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage (INTEGRAL-HPP)

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).

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: TEG6S

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).

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • Centre hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before TEG6S; Patients managed in a period of 12 months before the implementation of TEG6S®
After TEG6S; Patients managed in a period of 12 months after the implementation of TEG6S®	Device: TEG6S; Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrinogen consumption	Quantity of fibrinogen administered (in grams)	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of TEG6S®	Total number of TEG6S® carried out over a period of 12 months following its implementation	at 12 months
Estimated blood loss	Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials	up to 24 hours
Calculated blood loss	Estimated total volume of blood loss during PPH, using the following formula = ([initial Ht - Ht H24] × total blood volume × 100/35) + compensated blood loss (CBL) ; with: total blood volume in milliliters = basis weight × 65 × 1.4, and CBL in milliliters, corresponding to the number of RBC concentrates transfused (1 RBC corresponds to approximately 500 mL of blood at 35% Ht).	up to 24 hours
Consumption of packed red blood cells (RBC)	Number of packed red blood cells used	up to 24 hours
Consumption of fresh frozen plasma (FFP)	Number of fresh frozen plasma (FFP) used	up to 24 hours
Invasive haemostatic procedure	Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy)	up to 24 hours
Maternal death	Occurrence of maternal death at hospital	until leaving the hospital
ICU admission	Any admission in an intensive care unit	until leaving the hospital
ICU length of stay	Total length of stay in an intensive care unit/critical care (in days)	until discharge from the intensive care unit
Total length of stay	Total length of stay in hospital (in days)	until discharge from the intensive care unit
Acute anemia	Occurrence of anemia following postpartum hemorrhage, defined by a decrease in hemoglobin level of 4g/dL or more at 24h following delivery, compared to the last hemoglobin level known before delivery	at 24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Fatima BRIK, Centre hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Hemorrhage
• Other Study ID Numbers: 2024/0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No