Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain
研究概览
简要总结
The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as "Does TXA reduce the incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to severe adult TBI patients at Khon Kaen Hospital?"
详细描述
Traumatic brain injury (TBI) is a major public health problem with poor outcome especially with progressive intracranial haemorrhage (PIH) in severe patients. There are links between coagulopathic change after brain injury and delayed traumatic haemorrhage revealed by CT brain. Antifibrinolytic treatment can reduce blood loss after surgery and perhaps in moderate to severe TBI by similar haemostatic responses. It is justified to determine benefit for reversing hyperfibrinolysis after TBI. Tranexamic acid (TXA) has been shown to have significant clinical benefit in effectively reducing surgical bleeding in systematic reviews. It has been shown to have no effect on coagulation parameters and no demonstrated harmful effect in systematic reviews. This study is designed to determine the effectiveness of TXA in preventing PIH in patients with moderate to severe TBI. The treatment regimen if effective can be applied in general trauma practice worldwide.
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)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe injuries(post-resuscitation scores GCS 4-12)
- •age >= 16 year
- •non-penetrating TBI in 8 hours onset
- •first CT brain in 8 hours onset
- •non neurosurgical OR in 8 hours onset
排除标准
- •patients with coagulopathy
- •serum creatinine over than 2 mg%
- •with associated major organ injury requiring surgery within 8 hours of injury
- •pregnancy
- •receiving any medication which affects haemostasis
研究组 & 干预措施
Transamin
Drug: tranexamic acid
Loading 1 gram (~20 mg/kg) 100cc solution infuses in 30 minutes Maintenance 1 gram (~2.5 mg/kg/hr) 1000cc solution infuses in 8 hours
干预措施: tranexamic acid (Drug)
结局指标
主要结局
Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain
时间窗: 24 ± 8 hours
次要结局
- Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need(at discharge period)
研究者
Surakrant Yutthakasemsunt
Dr.
Khon Kaen University