CTRI/2018/05/014106已完成1 期
To compare the efficacy of combined use of intravenous and Intra-articular injection of Tranexamic acid with intra-articular administration alone in reducing blood loss in Primary Total Knee Arthroplasty: Randomized controlled trial
Yeshi Dorji1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月6日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compare Fall in Haemoglobin level,haematocrit and Drain output
研究概览
简要总结
To compare the efficacy of combined group(I.V and intra-articular) vs single group(intra-articular only) in reducing post operative blood loss in primary TKA patients
1gm of TXA is given I.V 15 mins before skin incision and Intra-articular injection is given after closure of joint capsule
Post operatively Heamoglobin and Haematocrit are evaluated on day 3, day5 and day 14
Drain output is measured after 24 hours post operative
Then blood loss of two groups are compared with data collected as mentioned above
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 Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •In combined Group-1gm of TXA using I.V injection 15 mins before skin incision and 1gm of TXA using intra-articular intra operatively after closure of joint capsule in primary TKA Single group-Receives only 1gm of TXA intra-articular intraoperatively after joint capsule closure in primary TKA.
排除标准
- •Patient unwilling for study-no consent Patients allergic to TXA Patient with known history of thromboembolic disease Patients with cardiovascular disease like MI Patients with history of cerebral vascular disease- stroke pre op renal dysfunction pre op coagulopathy plt less than 1.5lakh and INR more than 1.4.
结局指标
主要结局
Compare Fall in Haemoglobin level,haematocrit and Drain output
时间窗: post operative day Hb level on day 3, day 5 and day 14 | Drain output is measured after 24 hours post surgery
次要结局
- To evaluate the amount of blood loss with combined (intravenous and intra-articular) TXA in primary TKA(To evaluate amount of blood loss with only intra-articular administration of TXA in primary TKA)
研究者
研究点 (1)
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