Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. a Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of red blood cells returned to Blood and Tissue bank located in Josep Trueta hospital compared to red blood cells delivered at medical emergency system (SEM) units H2, G500 and G409.
研究概览
简要总结
Study Design: Single-center, not-randomized, open-label, two-arms controlled pilot clinical trial.
Health Condition: Patients with severe trauma with a need for transfusion and categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut) Polytrauma Code (PPT)
详细描述
Major hemorrhage in the setting of severe trauma patient is associated with significant morbidity and mortality. Hemorrhage is compounded by trauma induced coagulopathy of which hypo/dysfibrinogenemia and hypoperfusion play a significant role. There is a good evidence to suggest that hypofibrinogenemia in trauma is associated with worse outcomes and it is postulated that early replacement of fibrinogen and red blood cells packages may reduce hemorrhage and improve outcomes even in the pre-hospital phase of care. In this pilot study, the investigators will try to prove the feasibility and efficacy of managing the severe traumatic patient with red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate compared to standard treatment based on crystalloid fluid and TXA in the pre-hospital phase of care.
Early administration at pre-hospital phase of care of RBC, FC and TXA is feasible , secure and can help controlling trauma induced coagulopathy. Better outcomes in terms of mortality, less transfusion requirements and less crystalloid administration is expected
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years AND
- •Patients with severe trauma categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut). Polytrauma Code (PPT) AND
- •Evidence of bleeding or a high bleeding suspicion according to physician judgment OR o Predicted to need transfusion according to TICS (Yale Global Tics Severity Scale) score ≥10.
排除标准
- •Moribund patient with devastating injuries and expected to die within 1-hour OR
- •Known objection to blood components transfusion OR
- •Known acquired or congenital coagulopathies not related to the actual trauma OR
- •Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR
- •Known Pregnancy OR
- •Severe isolated traumatic brain injury OR
- •Hemorrhage not related to the actual trauma.
研究组 & 干预措施
conventional treatment
red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC)
干预措施: conventional treatment (Drug)
conventional treatment added to Crystalloids and TXA
administration of Crystalloids and TXA
干预措施: with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC),administration of Crystalloids and TXA. (Drug)
结局指标
主要结局
Percentage of red blood cells returned to Blood and Tissue bank located in Josep Trueta hospital compared to red blood cells delivered at medical emergency system (SEM) units H2, G500 and G409.
时间窗: 72 hours
number of transfusions used during 72 hours
次要结局
未报告次要终点
研究者
Cristina Martinez
Master of science, Study Coordinator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta