NCT04684719已完成3 期
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Jason Sperry
- 入组人数
- 1,020
- 试验地点
- 10
- 主要终点
- 30-day mortality
研究概览
简要总结
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.) Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion
- •2A.) Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport OR
- •2B.) Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport
排除标准
- •Wearing NO TOWAR opt-out bracelet
- •Age > 90 or < 18 years of age
- •Isolated fall from standing injury mechanism
- •Known prisoner or known pregnancy
- •Traumatic arrest with > 5 minutes of CPR without return of vital signs
- •Brain matter exposed or penetrating brain injury (GSW)
- •Isolated drowning or hanging victims
- •Objection to study voiced by subject or family member at the scene
- •Inability to obtain IV or intraosseous access
- •Isolated burns without evidence of traumatic injury
研究组 & 干预措施
Whole Blood
Experimental
Subjects will receive up to two units of whole blood as collected by local blood bank procedures and stored at 1-6 degrees Celsius initiated in the prehospital phase of care.
干预措施: low titer whole blood (Biological)
Standard Care
Active Comparator
Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
干预措施: Standard Care (Biological)
结局指标
主要结局
30-day mortality
时间窗: Enrollment through 30 days
All cause mortality within 30 days
次要结局
- Blood and blood component transfusion type(Enrollment through 24 hours)
- Prothrombin Time (PT)(Enrollment through 60 minutes and 24 hours)
- Age of whole blood(During Procedure)
- blood stream infection(Number of participants who develop blood stream infection through 30 days)
- Acute Respiratory Distress Syndrome (ARDS)(Number of participants who develop ARDS through 30 days)
- 3-hour mortality(Enrollment through 3 hours)
- Time to death(Enrollment through death or 30 days)
- Multiple Organ Failure (MOF)(Enrollment through 7 days or ICU discharge)
- Hospital-acquired pneumonia(Number of participants who develop pneumonia through 30 days)
- Transfusion reaction(Enrollment through 24 hours)
- 6-hour mortality(Enrollment through 6 hours)
- In-hospital mortality(Enrollment through hospital discharge or 30 days)
- Time to blood and blood component transfusion(Enrollment time to first transfusion)
- International Normalized Ratio (INR)(Enrollment through 60 minutes and 24 hours)
- 24-hour mortality(Enrollment through 24 hours)
- Blood and blood component transfusion amount(Enrollment through 24 hours)
- Incidence of coagulopathy by rapid thrombelastography (rTEG)(Enrollment through 60 minutes and 24 hours)
- Time to hemostasis(Enrollment through 4 hours)
- rTEG platelet function(Enrollment through 60 minutes and 24 hours)
- whole blood aggregometry(Enrollment through 60 minutes)
研究者
研究点 (10)
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