A Multi-centre, Prospective, Randomized Controlled Study to Compare Outcomes of Viscoelastic Haemostatic Assay (VHA)-Guided Resuscitation Versus Conventional Resuscitation Support in Haemorrhaging Trauma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 8
- 主要终点
- Proportion of subjects alive and free of massive transfusion
研究概览
简要总结
This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.
详细描述
Trauma is the most frequent cause of death in persons aged under 40, with half of these deaths resulting from uncontrolled bleeding. 1 in 4 of all severely injured and shocked patients develop a clotting abnormality termed Trauma Induced Coagulopathy (TIC) within minutes of injury, which causes blood to continue being lost from the body faster than it can be stemmed. Many more injured patients will go on to develop different types of coagulopathy at different times during the course of their treatment, either as a result of their body's ongoing response to trauma or as a consequence of their clinical care. Ultimately coagulopathic patients have increased blood transfusion requirements and suffer more adverse outcomes (e.g. multi organ failure).
Current management of coagulopathic, haemorrhaging trauma patients comprises the unguided transfusion of large volumes of red blood cells and clotting product supplements. Without rapidly available and validated diagnostics, products are delivered empirically to patients blind to the type and severity of TIC they may have or indeed even if they do not have TIC. This study will compare outcomes of viscoelastic haemostatic assay (VHA)-guided resuscitation versus conventional management of critically bleeding trauma patients. The hypothesis is that goal-directed haemostatic resuscitation of coagulopathic bleeding trauma patients will yield improved outcomes and reduced blood product demand, compared to empiric massive transfusion therapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult trauma patients (according to local definitions) will be enrolled if they:
- •Present with hemorrhagic shock at any time from the time of injury until admission to the emergency department (where shock is defined by HR>100 b/min and/or systolic BP<90 mmHg) AND activate the local massive transfusion protocol
- •Randomized within 3 hours of injury and 1 hour of admission to the emergency department
- •Agreement is provided on behalf of incapacitated patients by Personal Consultee or Nominated Consultee (e.g.trauma team leader)
排除标准
- •Any inclusion criteria are not met
结局指标
主要结局
Proportion of subjects alive and free of massive transfusion
时间窗: 24 hours
Proportion of subjects at 24 hours post-admission who are alive and free of massive transfusion (i.e. received 10 or more units of red blood cells within 24 hours)
次要结局
- 28d Mortality(28-days)
- Proportion of patients with corrected coagulopathy after first 8U RBC(28-days post admission)
- Time spent in coagulopathic condition until haemostasis(28-days post admission)
- 6hr Blood products transfused(6 hours)
- 28d ICU-free days(28 days)
- 90d QoL(90 days)
- 24hr Mortality(24 hours)
- Duration of coagulopathy(28-days post admission)
- Severity of coagulopathy(28-days post admission)
- Time to hemostasis(28-days post admission)
- 24hr Blood products transfused(24 hours)
- Transfusion-related complications(28-days)
- 6hr Mortality(6 hours)
- 90d Mortality(90-days)
- 28d Ventilator-free days(28 days)
- Symptomatic thromboembolic events(28 days)
- 28d/discharge QoL(28 days)
- Length of stay(28 days)
- Organ dysfunction(28-days)