Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.
详细描述
A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 90 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 CatSalut Polytrauma Code (PPT) AND
- •Evidence of bleeding or a high bleeding suspicion according to physician judgment OR
- •Predicted to need transfusion according to TICCS 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
Experimental treatment
The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.
干预措施: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] (Drug)
Experimental treatment
The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.
干预措施: Red blood cells concentrate (Biological)
Experimental treatment
The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.
干预措施: Tranexamic Acid (Drug)
Standard treatment
Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 24 hours post hospital admission
Mortality for any cause
Temperature storage conditions of the red blood cells concentrate
时间窗: 24 hours
Red bood cells concentrate out of temperature range for storage
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
时间窗: Basal (at the hospital arrival)
TEG6s(R) parameters that define TIC
Accountability
时间窗: 30 days
Red bood cells concentrate accountability
次要结局
- Adverse Events(30 days post hospital admission (or previously at hospital discharge))
- Crystalloid fluid requirements(30 days post hospital admission (or previously at hospital discharge))
- Ventilator-free days(30 days)
- Thromboembolism events(30 days)
- Transfusion requirements(30 days post hospital admission (or previously at hospital discharge))
- All-cause mortality(30 days post hospital admission)
- Water balance(72 hours of admission at the ICU)