Efficacy of Tranexamic Acid With/Without Drain in Knee Arthroplasty: A Study From Northwest Syria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Total Blood Loss
研究概览
简要总结
This prospective randomized clinical study is designed to evaluate the effects of intra-articular tranexamic acid (TNA), with or without suction drainage, on perioperative blood management in patients undergoing total knee arthroplasty (TKA) for degenerative arthritis. A total of 192 patients will be randomly assigned to three groups: Group 1 will receive TNA with suction drainage, Group 2 will receive TNA only, and Group 3 will receive suction drainage only.
The primary outcomes will be total blood loss and transfusion requirements. Secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion. The study will help clarify whether suction drainage is necessary when intra-articular TNA is used during TKA.
详细描述
Total knee arthroplasty (TKA) is commonly associated with significant perioperative blood loss, which may increase transfusion requirements and associated risks such as immunologic reactions, infection, and delayed recovery. Tranexamic acid (TNA) is an antifibrinolytic agent that inhibits fibrinolysis by blocking the activation of plasminogen. Suction drainage is frequently used to prevent hematoma formation, but its benefit in reducing transfusion needs remains controversial.
This single-center, prospective randomized study will enroll 192 patients undergoing unilateral TKA for degenerative arthritis. Participants will be assigned to three groups: (1) TNA with suction drainage, (2) TNA only, and (3) suction drainage only. TNA will be administered intra-articularly at a dose of 3 g in 100 mL normal saline after wound closure. When applied, suction drains will be activated two hours postoperatively.
The primary outcomes will be total blood loss and transfusion requirement. The secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion at two months. Statistical analysis will be conducted using ANOVA, repeated-measures t-tests, and chi-square tests, with significance set at p ≤ 0.05.
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
- None
盲法说明
Not applicable. The study was conducted as an open-label trial with no blinded parties.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative knee arthritis
- •Scheduled for unilateral total knee arthroplasty
排除标准
- •Rheumatoid arthritis
- •Cardiovascular diseases (e.g., angina, myocardial infarction, arrhythmia, cerebrovascular events)
- •Coagulation disorders or thromboembolic disorders
- •Severe infections
- •Other serious health issues
研究组 & 干预措施
Tranexamic Acid with Suction Drainage
Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. A closed suction drain was inserted intra-articularly and subcutaneously, activated two hours postoperatively.
干预措施: Intra-articular Tranexamic Acid + Suction Drainage (Drug)
Tranexamic Acid without Drainage
Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. No suction drain was used in this group.
干预措施: Intra-articular Tranexamic Acid (Drug)
Suction Drainage without Tranexamic Acid
Patients undergoing total knee arthroplasty had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered in this group.
干预措施: Suction Drainage Only (Device)
结局指标
主要结局
Total Blood Loss
时间窗: Within 72 hours after surgery
Total blood loss calculated using changes in hemoglobin concentration and the Good et al. formula.
次要结局
- Hidden Blood Loss(Within 72 hours after surgery)
- Drainage Volume(24 hours postoperatively)
- Number of Blood Transfusions(During hospital stay (up to 7 days postoperatively))
- Postoperative Limb Swelling(1, 2, 4, and 6 weeks postoperatively)
- Wound-related Complications(Within 6 weeks after surgery)
- Thromboembolic Events (DVT/PE)(Within 6 weeks after surgery)
- Postoperative Knee Range of Motion(2 months postoperatively)
研究者
Mhmoud Adnan Al salamah
Principal Investigator, Department of Orthopedic Surgery, Idlib University
Idlib University