Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 764
- 试验地点
- 3
- 主要终点
- postoperative bleeding
研究概览
简要总结
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.
The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.
The secondary objectives include comparing the 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 amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.
The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, 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
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
placebo-controlled
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
- •patients who provide written informed consent
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
Empirical 1: TXA and Placebo administration
Tranexamic acid administration, regardless of the result of rotational thromboelastometry.
Placebo administration, at LI60 < 85 % or A10< 40 mm in EXTEM of rotational thromboelastometry
干预措施: TXA administration (Drug)
Empirical 1: TXA and Placebo administration
Tranexamic acid administration, regardless of the result of rotational thromboelastometry.
Placebo administration, at LI60 < 85 % or A10< 40 mm in EXTEM of rotational thromboelastometry
干预措施: Placebo administration (Drug)
Empirical 2: TXA administration
Tranexamic acid administration, regardless of the result of rotational thromboelastometry.
Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
干预措施: TXA administration (Drug)
Goal-directed 1: Placebo administration
Placebo administration, regardless of the result of rotational thromboelastometry.
Tranexamic acid administration at LI60 < 85 % or A10 < 40 mm in EXTEM of rotational thromboelastometry
干预措施: TXA administration (Drug)
Goal-directed 1: Placebo administration
Placebo administration, regardless of the result of rotational thromboelastometry.
Tranexamic acid administration at LI60 < 85 % or A10 < 40 mm in EXTEM of rotational thromboelastometry
干预措施: Placebo administration (Drug)
Goal-directed 2: TXA and Placebo administration
Placebo administration, regardless of the result of rotational thromboelastometry.
Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
干预措施: Placebo administration (Drug)
结局指标
主要结局
postoperative bleeding
时间窗: 24 hours
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
次要结局
- postoperative transfusion amount(24 hours)
- postoperative transfusion rate(24 hours)
- the lowest postoperative hemoglobin value(24 hours)
- incidence of reoperation(1 week)
- amount of intraoperative cell salvage(1 hour)
- viscoelastic whole blood profile(1 hour)
- incidence of seizure(1 week)
- incidence of thromboembolic complications(1 week)
- duration of mechanical ventilation(1 week)
- length of stays in the ICU and hospital(1 week)
- total cost(2 week)
- incidence of taking renal replacement therapy(1 week)
- incidence of acute kidney injury(1 week)
- incidence of postoperative delirium(1 week)
- incidence of applying for mechanical circulatory support(1 week)
- in-hospital mortality(1 week)
- central laboratory blood tests(1 week)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center