Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage

NCT06473233 — Completed, 195 participants, Centre Hospitalier Sud Francilien

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT06473233, acronym INTEGRAL-HPP
StatusCompleted
Study typeObservational
Enrollment195 (Actual)
SponsorCentre Hospitalier Sud Francilien (Other)
ConditionsPostpartum Hemorrhage
InterventionsTEG6S (Device)
Datesstart 2024-10-09, primary completion 2025-03-06, completion 2025-03-06, first posted 2024-06-25, last updated 2025-03-14
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Postpartum Hemorrhage All trials of TEG6S

-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).

Expand all sections  ·  Collapse all

+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).

+Arms and interventions

ArmTypeInterventionsDescription
Before TEG6SPatients managed in a period of 12 months before the implementation of TEG6S®
After TEG6SDevice: TEG6SPatients managed in a period of 12 months after the implementation of TEG6S®
  • TEG6S (Device): Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician

+Outcome measures

Primary outcomes

  • Fibrinogen consumption [up to 24 hours]: Quantity of fibrinogen administered (in grams)

Secondary outcomes

  • Total number of TEG6S® [at 12 months]: Total number of TEG6S® carried out over a period of 12 months following its implementation
  • Estimated blood loss [up to 24 hours]: Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials
  • Calculated blood loss [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).
  • Consumption of packed red blood cells (RBC) [up to 24 hours]: Number of packed red blood cells used
  • Consumption of fresh frozen plasma (FFP) [up to 24 hours]: Number of fresh frozen plasma (FFP) used
  • Invasive haemostatic procedure [up to 24 hours]: Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy)
  • Maternal death [until leaving the hospital]: Occurrence of maternal death at hospital
  • ICU admission [until leaving the hospital]: Any admission in an intensive care unit
  • ICU length of stay [until discharge from the intensive care unit]: Total length of stay in an intensive care unit/critical care (in days)
  • Total length of stay [until discharge from the intensive care unit]: Total length of stay in hospital (in days)
  • Acute anemia [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

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Centre Hospitalier Sud FrancilienCorbeil-Essonnes, FranceFrance

+Investigators

  • Fatima BRIK, Principal investigator, Centre Hospitalier Sud Francilien