Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Fibrinogen consumption
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient informed of the research and refusing the use of the data
结局指标
主要结局
Fibrinogen consumption
时间窗: up to 24 hours
Quantity of fibrinogen administered (in grams)
次要结局
- Total number of TEG6S®(at 12 months)
- Estimated blood loss(up to 24 hours)
- Consumption of packed red blood cells (RBC)(up to 24 hours)
- Consumption of fresh frozen plasma (FFP)(up to 24 hours)
- Invasive haemostatic procedure(up to 24 hours)
- Maternal death(until leaving the hospital)
- ICU admission(until leaving the hospital)
- Acute anemia(at 24 hours)
- Total length of stay(until discharge from the intensive care unit)
- Calculated blood loss(up to 24 hours)
- ICU length of stay(until discharge from the intensive care unit)