Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).
研究概览
简要总结
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.
T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.
详细描述
In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war, and the high number of victims of each attack changes the logistical approach.
The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma and platelet concentrates, are the speed of delivery and availability. Using whole blood is a pragmatic solution to overcome these problems. This solution has been used for many years by the French Army to ensure platelet transfusion in traumatic hemorrhages
The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet concentrates) in the management of coagulopathy in patients admitted to hospital for traumatic hemorrhage.
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
- 是
入选标准
- •Severe trauma patients requiring the initiation of a massive transfusion protocol determined on
- •At least two Red flag score factors (according to pre-hospital data) :
- •Suspected pelvic fracture
- •Shock index (FC / PAS)> = 1
- •Microdose hemoglobin <13g
- •Average blood pressure <70 mmHg
- •Need for prehospital tracheal intubation
- •AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival:
- •Penetrating trauma
- •Focused Abdominal Sonography for Trauma (FAST) echo positive
- •Blood pressure <90 mmHg
- •Respiratory rate >120 bpm
- •AND/OR after clinical assessment and on the prediction of the practitioner in charge of the treatment of the injured person of the need to transfuse during the emergency management of the injured person
排除标准
- •Non-traumatic hemorrhage
- •Patients transfused with more than two PRBCs before the initiation of the massive transfusion protocol.
- •Anti-coagulation treatment
- •Pregnancy
- •Age < 18 years
- •Patient refusing administration of blood products
- •Patient transferred from another hospital
- •Patient nor transported by a physician-staffed prehospital emergency medical system
- •Burn patient (≥30% of body surface).
- •Patient under specific known transfusion protocol (for example : allo immunization...)
研究组 & 干预措施
Whole blood group
Damage control resuscitation for trauma care using whole blood.
干预措施: Whole blood transfusion (Drug)
Fractionated blood products group
Damage control resuscitation for trauma care using component therapy.
干预措施: Fractionated blood products transfusion (Drug)
结局指标
主要结局
Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).
时间窗: 6 hours following hospital admission
This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram).
次要结局
- Effectiveness of circulatory resuscitation(2 hours following hospital admission)
- Mortality(2 hours following hospital admission and Day 30 (or the last day of hospitalization))
- Mortality / Morbidity(24 hours following hospital admission)
- Impact on timeframe to obtain blood products(2 and 6 hours following hospital admission)
- Impact on time to start transfusion therapy(Time between admission and transfusion therapy)
- Evolution of coagulopathy(At inclusion, 2, 6 and 24 hours following hospital admission.)
- Tolerance of whole blood transfusion(Day 1, Day 2)
- Labile blood products transfused in the first 24 hours(24 hours following hospital admission)
- Cost of the strategy(Day 30 (or the last day of hospitalization))
- Biobank establishment(Through study completion, an average of 3 years)
- Evolution of coagulopathy.(At inclusion, 2, 6 and 24 hours following hospital admission)