Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
NCT Number: NCT06473233
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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Notify Me18 year and older
Female
Observational
Corbeil-Essonnes, France, 91106
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician
Time frame: up to 24 hours
Quantity of fibrinogen administered (in grams)
Time frame: at 12 months
Total number of TEG6S® carried out over a period of 12 months following its implementation
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
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).
Time frame: up to 24 hours
Number of packed red blood cells used
Time frame: up to 24 hours
Number of fresh frozen plasma (FFP) used
Time frame: up to 24 hours
Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy)
Time frame: until leaving the hospital
Occurrence of maternal death at hospital
Time frame: until leaving the hospital
Any admission in an intensive care unit
Time frame: until discharge from the intensive care unit
Total length of stay in an intensive care unit/critical care (in days)
Time frame: until discharge from the intensive care unit
Total length of stay in hospital (in days)
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
Centre Hospitalier Sud Francilien
Other
Acronym: INTEGRAL-HPP
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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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