Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
This study aims to examine whether tranexamic acid has an meaningful clinical effect on blood loss after high tibial osteotomy. This study design is a double-blind randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients receive tranexamic acid 2g for 10 minutes just before surgery. Primary outcome is hemoglobin level preoperatively, postoperative 1 day, 2 days, 3 days, 2 weeks. Secondary outcome included hematocrit level, hemovac drainage, total blood loss, need for transfusion, deep vein thrombosis, Visual Analog Pain Scale, and wound complication.
详细描述
High tibial osteotomy is proved treatment option for medial compartment osteoarthritis of knee joint. Especially, open wedge high tibial osteotomy might cause moderate amount of bleeding and hematoma formation. Bleeding and hematoma could be a reason of soft tissue infection and wound complications. Tranexamic acid (TXA) is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation. The objective of the study is to test whether preoperative tranexamic acid could reduce the postoperative complications due to bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients for high tibial osteotomy
- •Having medicare insurance
- •Accepted patients
排除标准
- •History of lower extremity infection or neurologic problems
- •Inflammatory arthritis
- •Using thrombins
- •History of treatment for anemia
- •History of thromboembolic event
- •Chronic kidney disease
研究组 & 干预措施
Tranexamic acid before high tibial osteotomy
Interventions
- Procedure/Surgery: High tibial osteotomy
- Drugs: Tranexamic acid
干预措施: High tibial osteotomy (Procedure)
Tranexamic acid before high tibial osteotomy
Interventions
- Procedure/Surgery: High tibial osteotomy
- Drugs: Tranexamic acid
干预措施: Tranexamic acid (Drug)
High tibial osteotomy only
Interventions
- Procedure/Surgery: High tibial osteotomy
干预措施: High tibial osteotomy (Procedure)
结局指标
主要结局
Hemoglobin level
时间窗: Change from Baseline Hemoglbin level at postoperative 2 weeks
次要结局
- Number of Participants with Need for transfusion(Postoperative 1, 2, 3 days)
- Amount of Hemovac drainage(Postoperative 1, 2, 3 days)
- Total blood loss(Postoperative 1, 2, 3 days)
- Number of Participants with Need for transfusion Deep vein thrombosis(Until postoperative 2 weeks)
- Visual Analog Pain Scale [0 - 10](Preoperative & postoperative 1, 2, 3 days, 2 weeks)
- Hematocrit level(Preoperative & postoperative 1, 2, 3 days, 2 weeks)
研究者
Yong In
Professor
The Catholic University of Korea