|

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

RECRUITINGN/ASponsored by Konkuk University Medical Center
Actively Recruiting
PhaseN/A
SponsorKonkuk University Medical Center
Started2023-08-01
Est. completion2025-04-30
Eligibility
Age19 Years+
Healthy vol.Accepted

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

Age: 19 Years+Healthy volunteers accepted
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

Conditions6

Coagulation Disorder, BloodFibrinolysis; HemorrhageHeart DiseaseHeart DiseasesTransfusion Related ComplicationVascular Diseases

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.