Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Arthroscopic Visual Clarity Score
研究概览
简要总结
This prospective randomized controlled trial aims to evaluate the efficacy and safety of intraosseous tranexamic acid administration during arthroscopic rotator cuff repair. Eligible patients undergoing arthroscopic rotator cuff repair will be randomly assigned in a 1:1 ratio to receive either intraosseous tranexamic acid or intraosseous normal saline placebo. Tranexamic acid will be administered at a dose of 15 mg/kg through intraosseous injection into the proximal humerus after anesthesia induction.
The primary outcome will be intraoperative arthroscopic visual clarity assessed using a five-grade visual clarity scoring system during different surgical stages. Secondary outcomes will include irrigation fluid volume, operative time, and frequency of irrigation pressure adjustments. Safety outcomes will include perioperative complications and laboratory assessments.
This study will determine whether intraosseous tranexamic acid can improve visualization of the arthroscopic surgical field and optimize surgical conditions during rotator cuff repair.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years;
- •Patients diagnosed with rotator cuff tear by shoulder MRI;
- •Patients scheduled for arthroscopic rotator cuff repair;
- •Ability to understand the study and provide written informed consent.
排除标准
- •Severe open injury or infection around the surgical area;
- •Allergy to tranexamic acid;
- •Previous shoulder surgery;
- •Coagulation disorders;
- •Current anticoagulant therapy that cannot be discontinued;
- •Pregnancy.
结局指标
主要结局
Arthroscopic Visual Clarity Score
时间窗: During arthroscopic rotator cuff repair surgery
Intraoperative arthroscopic visual clarity will be assessed during different surgical stages, including glenohumeral joint debridement, acromioplasty, and rotator cuff repair. A five-grade visual clarity scoring system will be used: Grade 1: Extremely poor visualization due to severe active bleeding. The surgical field cannot be adequately visualized and the procedure cannot proceed normally. Grade 2: Poor visualization with substantial bleeding interference. Surgical manipulation is significantly affected and additional hemostatic procedures are required. Grade 3: Moderate visualization. Mild to moderate bleeding is present and partially interferes with visualization, but surgery can proceed after routine management. Grade 4: Good visualization. Only minimal bleeding points are present, with limited interference and no requirement for additional hemostatic intervention. Grade 5: Excellent visualization. The surgical field is clear with no visible bleeding points and optimal visua
次要结局
- Irrigation Fluid Volume(During surgery)
- Operative Time(During surgery)
研究者
Hua Luo
Doctor
Taizhou Hospital