Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Requirement of number of units of blood transfusion
研究概览
简要总结
This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery.
详细描述
This was a single centre, parallel group, prospective randomized control study. 116 patients of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura. 16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1 gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of blood transfusion, number of days admitted in the hospital after surgery and evidence of deep vein thrombosis were monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The random allocation of the patients to either group was done by one of the investigators using a random number table.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from lower limb trauma
排除标准
- •Presence of old implant or infection at the fracture site,
- •Any blood coagulation disorder
- •Patients undergoing percutaneous wire placement procedures for fracture fixation
- •Polytrauma
- •Non-consenting patients
- •Psychiatric patient
研究组 & 干预措施
Group Tranexamic Acid
50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision.
干预措施: Tranexamic acid injection (Drug)
Control group
50 patients were kept as a control group and were not given TXA.
干预措施: Normal Saline (Other)
结局指标
主要结局
Requirement of number of units of blood transfusion
时间窗: Average of 15 days
From the date of surgery till time of discharge
次要结局
- Change in Haemoglobin level post surgery(Average of 15 days (From the date of surgery till time of discharge))
- Evidence of deep vein thrombosis by Wells Score(Average of 15 days (From the date of surgery till time of discharge))
- Number of days admitted in the hospital after surgery(Average of 15 days (From the date of admission till time of discharge))
研究者
Jaspreet Singh
Specialist Medical Officer
AP Jain Civil Hospital, Rajpura