The Effect of Tranexamic Acid on Blood Coagulation After Colloid Infusion During Surgery: Rotational Thromboelastography Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rotational thromboelastography
研究概览
简要总结
Colloid solution is generally used to maintain intravascular volume. It is reported to impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction.
Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clot. It is used to treat or prevent excessive blood loss during surgery and in other medical conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic acid.
We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration can improve the colloid-induced clot strength impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip
- •American Society of Anesthesiologist I or II
排除标准
- •Patients receiving an intraoperative transfusion
- •Patients receiving thrombin
- •Patients having venous thromboembolism
- •Patients having renal or hepatic disease
- •Patients having coagulopathy
- •Patient having heart failure
研究组 & 干预措施
Tranexamic acid
During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss.
In addition, 1 g of tranexamic acid in 100 ml normal saline is administered intravenously over 30 min after finishing the procedure of hip implant insertion.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Rotational thromboelastography
时间窗: 30 minutes before starting an operation and 30 minutes after finishing an operation
次要结局
- International normalized ratio of prothrombin time(30 minutes before starting an operation and 30 minutes after finishing an operation)
- Platelet(30 minutes before starting an operation and 30 minutes after finishing an operation)
- Hemoglobin(30 minutes before starting an operation and 30 minutes after finishing an operation)
- Activated partial thromboplastin time(30 minutes before starting an operation and 30 minutes after finishing an operation)
- Fibrinogen(30 minutes before starting an operation and 30 minutes after finishing an operation)
研究者
Hyo-Seok Na
Pf
Seoul National University Bundang Hospital