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

University of Indonesia (UI)

Status and phase: Completed; Phase 4

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

Treatments: Drug: Tranexamic Acid 100 MG/ML; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05708690

1706120543 (Other Identifier)

1706120530 (Other Identifier)

TRACS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups, including a placebo group

Tranexamic Acid Topical

Experimental group

Description:

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)

Treatment:

Drug: Tranexamic Acid 100 MG/ML

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: normal saline