REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 280
- 主要终点
- 24 Hour Mortality
研究概览
简要总结
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥15 years old
- •anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2
排除标准
- •Cardiopulmonary Resuscitation > 5 minutes
- •Penetrating cranial injury or exposed brain matter
- •Anticoagulation treatment
- •Transfer patients
- •Known pregnancy
研究组 & 干预措施
Standard of Care
standard resuscitation methods only
干预措施: Whole Blood, Plasma, Packed Red Blood Cells (Biological)
PCC
single dose of 4-Factor PCC in addition to standard resuscitation methods
干预措施: Prothrombin Complex Concentrate (Biological)
结局指标
主要结局
24 Hour Mortality
时间窗: 24 hours after enrollment
Assess if patient is alive at 24 hours post treatment
次要结局
未报告次要终点
研究者
Bellal A. Joseph, MD, FACS
Chief of the Division of Trauma, Acute Care, Burn, and Emergency Surgery
University of Arizona