Tranexamic Acid in Prehospital and In Hospital Civilian Trauma Care in Antifibrinolytic Therapy Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Survival at 24 hours
研究概览
简要总结
The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the safety and efficacy of Tranexamic Acid (TXA) use in the civilian prehospital and in hospital setting in cases of traumatic hemorrhagic shock.
详细描述
The Cal-PAT study is a multi-centered, prospective, observational cohort study. From March 2015 to July 2017, patients ≥ 18-years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified were considered for TXA treatment by first responders in the prehospital setting and physicians in hospital. A control group was formed of patients seen in the five years prior to data collection cessation (June 2012 to July 2017) at each receiving center who were not administered TXA. Control group patients were selected through propensity score matching based on gender, age, injury severity scores, and mechanism of injury. The primary outcome measured was mortality. Secondary outcomes measured included the total blood products transfused, the hospital and intensive care unit length of stay, and the incidence of known adverse events associated with TXA.
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
- •Blunt or penetrating trauma with signs and symptoms of hemorrhagic shock
- •Systolic blood pressure less than 90 mmHg at scene of injury, during air and/or ground medical transport, or on arrival to designated trauma centers
- •Any sustained blunt or penetrating injury within 3 hours
- •Patient who are considered to be at high risk for significant hemorrhage
- •Estimated blood loss of 500 milliliters int he field accompanied with HR >120
- •Bleeding not controlled by direct pressure or tourniquet
- •Major amputation of any extremity above the wrists and above the ankles
排除标准
- •Any patient under 18 years of age
- •Any patient with an active thromboembolic event (within the last 24 hours) i.e. active stroke, myocardial infarction, or pulmonary embolism
- •Any patient with a hypersensitivity or anaphylactic reaction to TXA
- •Any patient more than 3 hours post injury
- •Traumatic arrest with > 5 minutes CPR without return of vital signs
- •Penetrating cranial injury
- •Traumatic brain injury with brain matter exposed
- •Isolated drowning or hanging victims
- •Documented cervical cord injury with motor deficit
研究组 & 干预措施
Prehospital Tranexamic Acid
1 gram of Tranexamic Acid will be given during medical transport
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Survival at 24 hours
时间窗: 24 hours
Mortality at 24 hours
Survival at 48 hours
时间窗: 48 hours
Mortality at 48 hours
Survival at 28 days
时间窗: 28 days
Mortality at 28 days
次要结局
- Length of Hospital Stay(28 days)
- Adverse Events(28 days)
- Blood Transfusion(24 hours)
研究者
Michael Neeki
Director of Research - Emergency Medicine
Arrowhead Regional Medical Center