Prehospital Plasma or Red Blood Cell Transfusion Strategy in Major Bleeding; PRIEST Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Base deficit
研究概览
简要总结
The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion.
A) Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only
Hypothesis:
- Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit).
- Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.
详细描述
Rationale for the study:
The warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, RBC or combination of both.
Despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. So far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.
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
- •Major bleeding requiring prehospital transfusion
排除标准
- •Transfusion with blood products already initiated
研究组 & 干预措施
Plasma
Transfusion with plasma
干预措施: Blood products (Biological)
Red Blood cells
Transfusion with red blood cells
干预措施: Blood products (Biological)
结局指标
主要结局
Base deficit
时间窗: At hospital arrival (with in 1 hour)
Arterial-gas analysis upon arrival with parameter base deficit as primary outcome
次要结局
- International Normalized Ratio (INR)(At hospital arrival (with in 2 hours))
- Endothelium markers(At hospital arrival (with in 2 hours))
- Endogenous thrombin potential (ETP)(At hospital arrival (with in 2 hours))
- 30 days mortality(mortality within 30 days)
- Activated Partial Thromboplastin Time (APTT)(At hospital arrival (with in 2 hours))
- In hospital plasma transfusion requirements(Within in the first 24 hours after hospital arrival)
- In hospital red blood cell transfusion requirements(Within in the first 24 hours after hospital arrival)
- In hospital platelet transfusion requirements(Within in the first 24 hours after hospital arrival)