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OpenTrials
Completed

NCT Number: NCT06473233

Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEG6S

Device

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

Primary outcomes

  1. Fibrinogen consumption

    Time frame: up to 24 hours

    Quantity of fibrinogen administered (in grams)

Secondary outcomes

  1. Total number of TEG6S®

    Time frame: at 12 months

    Total number of TEG6S® carried out over a period of 12 months following its implementation

  2. Estimated blood loss

    Time frame: up to 24 hours

    Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials

  3. Calculated blood loss

    Time frame: up to 24 hours

    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).

  4. Consumption of packed red blood cells (RBC)

    Time frame: up to 24 hours

    Number of packed red blood cells used

  5. Consumption of fresh frozen plasma (FFP)

    Time frame: up to 24 hours

    Number of fresh frozen plasma (FFP) used

  6. Invasive haemostatic procedure

    Time frame: up to 24 hours

    Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy)

  7. Maternal death

    Time frame: until leaving the hospital

    Occurrence of maternal death at hospital

  8. ICU admission

    Time frame: until leaving the hospital

    Any admission in an intensive care unit

  9. ICU length of stay

    Time frame: until discharge from the intensive care unit

    Total length of stay in an intensive care unit/critical care (in days)

  10. Total length of stay

    Time frame: until discharge from the intensive care unit

    Total length of stay in hospital (in days)

  11. Acute anemia

    Time frame: at 24 hours

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: INTEGRAL-HPP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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