Combined Intravenous and Topical Tranexamic Acid in Total Hip Arthroplasty: A Prospective Comparative Study With Rotational Thromboelastometry Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
研究概览
简要总结
This prospective study evaluates whether combined intravenous and topical administration of tranexamic acid (TXA) can safely reduce blood loss in patients undergoing primary total hip replacement surgery. Tranexamic acid is commonly used during orthopedic surgery to decrease bleeding and reduce the need for blood transfusions.
Participants undergoing elective primary total hip arthroplasty are assigned to receive either intravenous TXA alone or a combination of intravenous and topical TXA applied directly around the hip joint during surgery. The study compares postoperative blood loss, changes in hemoglobin levels, transfusion requirements, length of hospital stay, and postoperative complications between the treatment groups.
The study also uses rotational thromboelastometry (ROTEM), a specialized blood coagulation monitoring method, to evaluate whether combined TXA administration affects blood clotting or increases the risk of thromboembolic complications such as deep vein thrombosis or pulmonary embolism.
详细描述
Total hip arthroplasty (THA) is frequently associated with substantial perioperative blood loss, which may increase the need for blood transfusions and prolong hospitalization. Tranexamic acid (TXA), an antifibrinolytic agent, is widely used in orthopedic surgery to reduce bleeding; however, the optimal route of administration and its effects on coagulation remain subjects of ongoing investigation.
This prospective comparative study evaluates the efficacy and safety of combined intravenous and topical TXA administration compared with intravenous TXA alone in patients undergoing elective primary cementless THA for primary osteoarthritis. Patients are randomized into two treatment groups. The intravenous group receives 1 g TXA before surgical incision, while the combined group receives 1 g intravenous TXA preoperatively together with an additional 2 g topical TXA applied locally around the prosthesis during wound closure.
The primary objective is to determine whether combined administration reduces postoperative blood loss and transfusion requirements. Secondary objectives include assessment of perioperative hemoglobin changes, wound complications, length of hospital stay, and the incidence of thromboembolic complications.
To further evaluate coagulation safety, serial rotational thromboelastometry (ROTEM) measurements are performed before surgery, during surgery, and after surgery. ROTEM analysis is used to assess clot formation, clot strength, fibrinolysis, and potential hypercoagulability associated with TXA administration. The study aims to determine whether dual-route TXA administration improves perioperative blood management without increasing thromboembolic risk in patients undergoing primary THA.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing elective primary cementless total hip arthroplasty for primary hip osteoarthritis
- •Preoperative hemoglobin level ≥130 g/L
- •Ability to provide written informed consent
排除标准
- •Post-traumatic or secondary hip arthritis
- •Known allergy or hypersensitivity to tranexamic acid
- •History of deep vein thrombosis or pulmonary embolism
- •Current anticoagulant therapy
- •Known coagulation disorder
- •Body mass index (BMI) >40 kg/m²
- •Significant hepatic or renal dysfunction
- •Type 1 diabetes mellitus
- •Significant cardiovascular disease
- •Traumatic indication for total hip arthroplasty