Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TXA administration, Placebo administration.
- Who it may be relevant to
- Registry conditions: Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
Overview
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.
Interventions
- Drug TXA administration
Tranexamic acid intravenous administration - Drug Placebo administration
Placebo (normal saline) intravenous administration
Primary outcome measures
- postoperative bleeding [Time frame: 24 hours]
Secondary outcome measures (12)
- postoperative transfusion amount [Time frame: 24 hours]
- postoperative transfusion rate [Time frame: 24 hours]
- the lowest postoperative hemoglobin value [Time frame: 24 hours]
- incidence of reoperation [Time frame: 1 week]
- amount of intraoperative cell salvage [Time frame: 1 hour]
- viscoelastic whole blood profile [Time frame: 1 hour]
- incidence of seizure [Time frame: 1 week]
- incidence of thromboembolic complications [Time frame: 1 week]
- duration of mechanical ventilation [Time frame: 1 week]
- length of stays in the ICU and hospital [Time frame: 1 week]
- total cost [Time frame: 2 week]
- incidence of taking renal replacement therapy [Time frame: 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Diagnostic
Study locations
South Korea · 3 centers
- Konkuk University Medical Center — Seoul
- Samsung Medical Center — Seoul
- Asan Medical Center — Seoul
Publications
- Nam JS, Oh CS, Kim JY, Choi DK, Oh AR, Park J, Lee JH, Yun SC, Kim KW, Jang MU, Kim TY, Choi IC. A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in cardiovascular surgery (GD PMID 39334224
Identifiers
NCT: NCT05806346 · HI22C1952-1-3