A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- fibrinogen concentration (clauss)
研究概览
简要总结
Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency
- •Trauma patient admitted in participating trauma care centers
- •Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
- •Inclusion performed within the first 6 hours after trauma.
排除标准
- •Patient taking anticoagulants
- •Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
- •Minor Patient
- •Pregnant or breastfeeding women
研究组 & 干预措施
Freezed-dried plasma
transfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)
干预措施: Freezed-dried plasma (Drug)
Fresh-frozen plasma
transfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)
干预措施: Fresh-frozen plasma (Drug)
结局指标
主要结局
fibrinogen concentration (clauss)
时间窗: 45 minutes after the admission on day 1 after trauma
次要结局
- time frame of transfusion of 4 plasma(time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission)