Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- CRT maximal amplitude
研究概览
简要总结
The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.
详细描述
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •pregnancy
- •refusal of allogenic blood transfusion
- •taking thrombin
- •history of thromboembolic and familial hypercoagulability disease
- •recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
- •hypersensitive to TXA
- •histroy of convulsion or epilepsy
- •taking hemodialysis
- •history of Heparin-induced thrombocytopenia
研究组 & 干预措施
TXA TEG6-triggered
When LY30≥3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
干预措施: TEG6 (Diagnostic Test)
TXA empirical
Empirical Tranexamic acid (TXA) administration after the anesthesia induction
干预措施: TXA (Drug)
TXA TEG6-triggered
When LY30≥3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
干预措施: TXA (Drug)
TXA TEG6-non-triggered
When LY30<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered
干预措施: TEG6 (Diagnostic Test)
结局指标
主要结局
CRT maximal amplitude
时间窗: 24 hours
maximal amplitude of CRT test
次要结局
- CK reaction time(24 hours)
- CRT maximal lysis(24 hours)
- seizure(48 hours)
- thromboembolism(48 hours)
- postoperative bleeding(48 hours)
- CFF maximal amplitude(24 hours)
- CK alpha angle(24 hours)
- fresh frozen plasma(6 hours)
- packed RBC(6 hours)
- platelet(6 hours)
- re-operation(48 hours)
- Hemoglobin(24 hours)
- cryoprecipitate(6 hours)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center