Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery

Conditions: Coronary Artery Disease, Valvular Heart Disease, Surgical Blood Loss

Summary

This is a single-center, double-blind, randomized controlled trial (RCT) comparing two groups of application of topical dose of tranexamic acid (TxA) versus placebo in patients undergoing coronary artery bypass graft (CABG), off pump coronary bypass graft cardiac surgery (OPCAB), and adult heart valve surgery. The primary outcomes of this study comprised of two parameters; post operative bleeding and blood product transfusion. The primary outcomes were assessed during the operation, until 48-hour post operative.

Eligibility Criteria

Inclusion Criteria:Patients ages > 18 years oldPatients who are scheduled electively for cardiac surgery in National Heart Center Harapan Kita, Jakarta, IndonesiaPatients with heart valve disease indicated for aortic or mitral repair/replacePatients with coronary artery disease indicated for CABG or OPCAB surgeryAortic and/ mitral valve surgery concomitant with tricuspid repairPatients who are agreed to participate in this studyExclusion Criteria:Not willing to become research subjectsAllergy to tranexamic acidUndergoing minimally invasive surgeryUndergoing double valve (aorta & mitral) procedure and double procedure (CABG+valve, valve+maze)Emergency surgeryHistory of bleeding disorder or coagulopathyHistory of thromboembolic or hemorrhagic diseaseActive Infective endocarditisHistory of previous cardiac surgeryEstimated glomerular filtration rate <30 mL/min or on dialysisReceiving oral therapy with clopidogrel, aspirin, dabigatran, or rivaroxaban in the last five daysReceiving chronic warfarin therapy who have not stopped their medication and have an international normalized ratio (INR) >1.5 before surgeryPre-operative thrombocytopenia (<50,000 platelets per µL)Pregnancy or breast feedingRefusal of blood productsPericarditis

Source: ClinicalTrials.gov (NCT05708690). StuddyBuddy aggregates publicly available trial information.