Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 764
- Locations
- 3
- Primary Endpoint
- postoperative bleeding
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
placebo-controlled
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
- •patients who provide written informed consent
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: Placebo administration (Drug)
Outcomes
Primary Outcomes
postoperative bleeding
Time Frame: 24 hours
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
Secondary Outcomes
- 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)
Investigators
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center