Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage: a Prospective Multicenter Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method
研究概览
简要总结
In France in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.
详细描述
In France in 2021, 11.6% of deliveries were complicated by postpartum hemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.
The hypothesis of the study is a concordance between the measurement of fibrinogen by the qLabs®FIB Monitoring system and by the Clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level < 2 g/L.
The prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration < 2g predictive of an unfavorable evolution in the context of severe PPH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patients having been informed of the study and not having objected to their participation and treated for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours postpartum, whatever the route delivery (vaginal route and caesarean section).
排除标准
- •Opposition to participation in the study
- •Presence of a constitutional fibrinogen deficiency
- •Patients under guardianship or curatorship
研究组 & 干预措施
Patients
Patients giving birth in the Cochin Port Royal and Necker Enfants Malades (APHP) maternity units and cared for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours of postpartum, regardless of the route of delivery (vaginal delivery and cesarean section).
干预措施: Fibrinogen concentration by the qLabs®FIB Monitoring system (Biological)
结局指标
主要结局
Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method
时间窗: Through study completion, an average of 1 year
Calculation of the average bias and the 95% limits of agreement between the measurement of qLabs®FIB fibrinogen in the delivery room and Clauss fibrinogen at the medical biology laboratory using the Bland and Altman graphic method. A difference of 0.1 g between the two techniques will be considered acceptable to identify patients with a fibrinogen level \< 2 g/L.
次要结局
- Evaluation of the ease of use of qLabs®FIB by the anesthesia team(Through study completion, an average of 1 year)
- Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods(Through study completion, an average of 1 year)
- Evaluation of measurement failure by qLabs®FIB(Through study completion, an average of 1 year)