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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Valvular Heart Disease; Surgical Blood Loss
• Interventions: Drug: Tranexamic Acid 100 MG/ML; Drug: normal saline

• Registration Number: NCT05708690
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

A single center randomized controlled trial (RCT) was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia as the tertiary cardiovascular referral hospital. The RCT was conducted from October 1 th, 2022 until January 6 th, 2023 (current status: completed). This study aims to determine whether topical tranexamic acid is more effective on the amount of bleeding and the need for postoperative blood product transfusion compared with placebo in patients undergoing cardiac surgery and specifically measure the difference outcome between coronary artery bypass graft (CABG), off pump coronary bypass graft cardiac surgery (OPCAB), and adult heart valve surgery. The control group in this study is given 100 mL of normal saline. The subjects were adults undergoing elective cardiac surgery (CABG, OPCAB, and heart valve surgery). Both the patients and the principal investigators were blinded for the treatment-control allocation. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. 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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-01-06
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients ages > 18 years old
• Patients who are scheduled electively for cardiac surgery in National Heart Center Harapan Kita, Jakarta, Indonesia
• Patients with heart valve disease indicated for aortic or mitral repair/replace
• Patients with coronary artery disease indicated for CABG or OPCAB surgery
• Aortic and/ mitral valve surgery concomitant with tricuspid repair
• Patients who are agreed to participate in this study

Exclusion Criteria

• Not willing to become research subjects
• Allergy to tranexamic acid
• Undergoing minimally invasive surgery
• Undergoing double valve (aorta & mitral) procedure and double procedure (CABG+valve, valve+maze)
• Emergency surgery
• History of bleeding disorder or coagulopathy
• History of thromboembolic or hemorrhagic disease
• Active Infective endocarditis
• History of previous cardiac surgery
• Estimated glomerular filtration rate <30 mL/min or on dialysis
• Receiving oral therapy with clopidogrel, aspirin, dabigatran, or rivaroxaban in the last five days
• Receiving chronic warfarin therapy who have not stopped their medication and have an international normalized ratio (INR) >1.5 before surgery
• Pre-operative thrombocytopenia (<50,000 platelets per µL)
• Pregnancy or breast feeding
• Refusal of blood products
• Pericarditis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid Topical	Tranexamic Acid 100 MG/ML	The treatment of interest was application of Topical Tranexamic Acid (5 gram in 50 mL warm normal saline). The topical will be poured into the pericardial and mediastinal cavities (after protamine administration), and sternum (before chest closure)
Placebo	normal saline	The control group is given 100 mL of warm normal saline. The topical will be poured into the pericardial and mediastinal cavities (after protamine administration), and sternum (before chest closure).

Primary Outcome Measures

Name	Time	Method
6-hour postoperative bleeding	within 6-hour after the surgery	The study parameter is asses the accumulation of drain production within 6 hours postoperatively after surgical procedure
Initial Postoperative bleeding	immediately after the surgery	The study parameter is assessed by postoperative chest tube production immediately after the surgery
24-hour postoperative bleeding	within 24-hour after the surgery	The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure
48-hour postoperative bleeding	within 48-hour after the surgery	The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure
Postoperative blood product transfusion	participants will be followed for the duration of ICU and intermediate ward stay, an expected average of 5-7 days	The amount of red blood cell, fresh frozen plasma, thrombocyte concentrate, and cryoprecipitate transfusions the patient receive postoperatively during their stay in the hospital.

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita; 🇮🇩 Jakarta, DKI Jakarta, Indonesia