Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- postoperative drainage (mL)
研究概览
简要总结
The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection.
详细描述
Detail : Randomization of Patients for intra-surgical site topical tranexamic acid injection
Objective : To compare the efficacy of topical tranexamic acid (TXA) injection into the surgical wound versus placebo injection in reducing blood loss and drainage output in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) surgery.
Methods:
Patient: Patients with degenerative spine conditions undergoing single-level MI-TLIF surgery, who received treatment at Ramathibodi Hospital and Chakri Naruebodindra Medical Institute from 2024 to 2027.
Randomization : Patients will be randomly by various block randomization (1:1) was performed using STATA 16.0 to ensure that the two groups were comparable in size and that the sequence of randomization was unpredictable.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-80 years old
- •Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF
排除标准
- •Revision surgery
- •Patients who had high risk of complication from TXA
- •History of seizure, PE, DVT, thromboembolic episode
- •History of TXA allergy
- •Patients who had high risk for bleeding
- •U/D : CKD stage more than IIIb (GFR< 45 ml/min/1.73m2), hepatic disease, bleeding disorder
- •On anticoagulation drug or antiplatelet drug in 7 days before surgery
- •Abnormal coagulation profile (INR > 1.5) or CBC (platelet < 100000)
研究组 & 干预措施
Topical tranexamic acid (TXA) injection
receive an injection of topical tranexamic acid (TXA) into the surgical site
干预措施: Tranexamic acid (Drug)
Placebo group
receive an injection Normal saline into the surgical site
干预措施: Normal saline (Drug)
结局指标
主要结局
postoperative drainage (mL)
时间窗: 120 hours
Fluid drainage after operation
次要结局
- duration of drain maintenance (day)(120 hours)
- calculated total blood loss (mL)(120 hours)
- intraoperative blood loss (mL)(Intraoperative time)
- length of hospital stay (day)(120 hours)
- complication of tranexamic acid (TXA) and surgery(%)(120 hours)
研究者
Thanawan Longsuwan
Doctor
Ramathibodi Hospital