Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid Administration of Trauma Patients: A Randomized, Double-blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
TXA is currently administered pre-hospital in Canada, Germany, United Kingdom and Israel . These studies demonstrated that TXA use did not result in any detectable complications or adverse events. It is considered an ideal pre-hospital treatment because: (a) patients with severe hemorrhage die early more often than patients without hemorrhage; (b) it seems that the earlier treatment is administered, the better; (c) it is stable and easily stored; and (d) it is easily administered by paramedics. Herein, the study aimed to evaluate the effect of administration of second dose of Tranexamic acid infusion in the hospital setting in comparison to not receiving the second dose on the outcomes of trauma patients with an evidence of significant hemorrhage.
Recently, HGH ambulance service has included pre-hospital administration of TXA in trauma patients with significant hemorrhage. So, all eligible trauma patients will receive pre-hospital TXA (first dose) slowly over 10 minutes by the critical care paramedics as standard of care.
Inclusion Criteria: All adult trauma male and female patients (≥18 or <90 years) with evidence of significant hemorrhage (systolic blood pressure <90 mmHg or heart rate >110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds and received first dose of prehospital TXA will be included in the study.
Exclusion criteria:
- Age > 90 or < 18 years of age
- Inability to obtain intravenous access (intraosseous access not sufficient)
- Documented cervical cord injury with motor deficit
- Known prisoner
- Known pregnancy
- 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
- Wearing an opt out bracelet. Patient data will include demographics, time since injury, type of injury (blunt or penetrating), Glasgow Coma Score(GCS), Injury severity score (ISS), systolic blood pressure, respiratory rate, central capillary refill time, estimated number of hours since injury, laboratory findings, blood transfusion, units of transfused blood, management, complications and outcome.
The primary outcome will be death in hospital within 4 weeks of injury. Secondary outcomes will be morbidity (thromboembolic events, sepsis, Acute respiratory distress syndrome and organ failure), and number of blood transfusions (Massive transfusion protocol) and hospital length of stay.
详细描述
Study design It is a single-center, prospective, double-blind, randomized, placebo-controlled trial.
Study population All severely injured male and female patients with evidence of significant hemorrhage (systolic blood pressure <90 mmHg or heart rate >110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds will be administered TXA slowly over 10 minutes at the prehospital settings by critical care paramedics as standard of care are eligible for participation in this trial.
Sample size estimation:
The present clinical trial is based on CRASH-2 study [2] in which the sample size was more than 20,000 using the followings primary outcomes estimates such as all-cause-mortality 14.5% (TXA) vs. 16% (Placebo) and bleeding: 4.9% (TXA) vs. 5.7% (Placebo). According to CRASH-2 study approximately 30% of all patients randomized presented with significant hypotension (blood pressure < 90 mm Hg) considered to have significant hemorrhage.
This is a unique study to assess the effect of second dose of tranexamic acid in the hospital setting and there are no precise estimates available on the primary outcome particularly in our population. According to CRASH-2 trial, approximately 30% of all randomized patients presented with significant hypotension (BP <90mmHg) indicated hemorrhagic shock. Therefore, taking the prevalence of hemorrhage to be 30% with 5% confidence limit and 80% power; a total of 335 trauma patients need to be included in the study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All adult trauma male and female patients (≥18 or <90 years) with evidence of significant hemorrhage (systolic blood pressure <90 mmHg or heart rate >110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds [2] and received first dose of prehospital TXA will be included in the study.
排除标准
- •Age > 90 or < 18 years of age
- •Inability to obtain intravenous access (intraosseous access not sufficient)
- •Documented cervical cord injury with motor deficit
- •Known prisoner
- •Known pregnancy
- •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
- •Wearing an opt out bracelet.
研究组 & 干预措施
Tranexamic acid
group-I will include 110 patients with initial pre-hospital TXA administered slowly over 10 minutes followed by an intravenous infusion of 1 g TXA to be given and completed over 8 h in the hospital
干预措施: Tranexamic Acid (Drug)
Placebo
group-II will include 110 patients with initial pre-hospital TXA administered slowly over 10 minutes but will receive placebo (normal saline) infusion to be given and completed over 8 h in the hospital
干预措施: Placebo (Other)
结局指标
主要结局
mortality
时间窗: 4 weeks post injury
Number of participants who died from each study arm
次要结局
- morbidity(4 weeks post injury)
- number of blood transfusions(4 weeks post injury)
- Hospital length of stay(4 weeks post injury)
研究者
Dr. Ayman El-Menyar
Director, Trauma & Vascular Research
Hamad Medical Corporation