Randomised controlled trial on the role of Tranexamic acid in patients with open fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- 3. Need for blood transfusion: Proportion of patients transfused and total number of units transfused. In cases requiring a second surgery, total units transfused till the second surgery.
研究概览
简要总结
This protocol outlines a randomized controlled trial assessing the efficacy of a two-dose intravenous tranexamic acid regimen in adults with open fractures. The study aims to determine whether administering 1 gram of TXA at presentation and another after 8 hours reduces perioperative blood loss compared to single-dose TXA and placebo. It involves 250 participants divided equally into three groups. Primary outcomes include estimated blood loss and transfusion requirements, while secondary outcomes cover complications, thromboembolic events, hospital stay, and mortality. The trial ensures ethical conduct, informed consent, and double-blind randomization to maintain scientific validity and patient safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than or equal to 18 years Gustilo Anderson Type I,II,III open fractures Informed consent obtained.
排除标准
- •Known allergy to Tranexamic Acid History of thromboembolic disease DVT, PE, MI, stroke On anticoagulants or antiplatelet therapy at presentation Renal dysfunction (CrCl less than 30 mL per min) Hepatic failure Pregnancy or lactation.
结局指标
主要结局
3. Need for blood transfusion: Proportion of patients transfused and total number of units transfused. In cases requiring a second surgery, total units transfused till the second surgery.
时间窗: At presentation | 8 hours | Postoperative (24, 48,72 hours and 7 day) | Daily until discharge | At discharge
4. Intraoperative blood loss: Documented by the anaesthesia and surgical team
时间窗: At presentation | 8 hours | Postoperative (24, 48,72 hours and 7 day) | Daily until discharge | At discharge
1.Estimated total blood loss until discharge: Includes intraoperative suction volume, gauze weighing, drain output (if used), and visible postoperative bleeding.
时间窗: At presentation | 8 hours | Postoperative (24, 48,72 hours and 7 day) | Daily until discharge | At discharge
2. Haemoglobin and haematocrit changes: Measured at baseline, 24, 48, 72 hours and 7 days postoperatively.
时间窗: At presentation | 8 hours | Postoperative (24, 48,72 hours and 7 day) | Daily until discharge | At discharge
次要结局
- 1. Platelet count at baseline & postoperatively (to assess coagulopathy)(2. Wound-related complications: infection, hematoma, wound necrosis, dehiscence)
研究者
Arjit Bansal
Postgraduate Institute of medical education and research