Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Emergency department discharge
研究概览
简要总结
Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury
详细描述
TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. Results from randomised trials (CRASH-3 and NCT01990768) show that early treatment with TXA (given intravenously) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking will be done by an independent clinical trials supply company. It will involve the removal of the original manufacturer's label and replacement with the clinical trial label bearing the randomisation number, which will be used as the pack identification. Apart from the randomisation number, all pack label texts will be identical for tranexamic acid and placebo.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older (actual or estimated)
- •History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)
- •Has one or more of the following:
- •has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)
- •nausea or vomiting
- •Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone)
- •Not living in a nursing home, mental health institution or prison
- •Patient will be conveyed to or is admitted to a participating hospital
排除标准
- •- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
研究组 & 干预措施
Active
A single dose of Tranexamic acid 500mg given by intramuscular injection
干预措施: Tranexamic Acid 500 MG (Drug)
Placebo
One Injection of the placebo which is 10 mL Sodium Chloride (0.9%)
干预措施: Tranexamic Acid 500 MG (Drug)
结局指标
主要结局
Emergency department discharge
时间窗: within 24 hours
discharge
次要结局
- All cause mortality(within 28 days)
- Disability(within 28 days)
- Global assessment of ability to self-care(within 28 days)
- Neurosurgery(within 28 days)
- Days in ICU(within 28 days)
- Re-admission to hospital(within 28 days)
- Intracranial bleeding on CT scan(within 48 hours)
- Head injury related death(within 48 hours)
- Vascular occlusive events(within 28 days)
- Seizures(within 28 days)
- Intramuscular injection site reaction(within 28 days)
- Pneumonia(within 28 days)
- Adverse events(within 28 days)
- Dementia(1 year)
- Key TBI associated outcomes at 1 year(1 year)