NCT05806346 Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
| NCT ID | NCT05806346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Konkuk University Medical Center |
| Condition | Heart Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 764 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 764 participants in total. It began in 2023-08-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Tae-Yop Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Konkuk University Medical Center
Frequently Asked Questions
Who can join the NCT05806346 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Heart Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05806346 currently recruiting?
Yes, NCT05806346 is actively recruiting participants. Contact the research team at taeyop@gmail.com for enrollment information.
Where is the NCT05806346 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT05806346 clinical trial?
NCT05806346 is sponsored by Konkuk University Medical Center. The principal investigator is Tae-Yop Kim, MD, PhD at Konkuk University Medical Center. The trial plans to enroll 764 participants.