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

January 31, 2023 updated by: Dudy Arman Hanafy, Sp. BTKV (K), MARS, Indonesia University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 11410
        • National Cardiovascular Center Harapan Kita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tranexamic Acid Topical
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)
Tranexamic acid is a synthetic derivative of lysine used as an antifibrinolytic in the treatment and prevention of major bleeding. Tranexamic acid competitively and reversibly inhibits the activation of plasminogen via binding at several distinct sites, including four or five low-affinity sites and one high-affinity site, the latter of which is involved in its binding to fibrin. The binding of plasminogen to fibrin induces fibrinolysis - by occupying the necessary binding sites tranexamic acid prevents this dissolution of fibrin, thereby stabilizing the clot and preventing hemorrhage
Other Names:
  • Tranexamic Acid
PLACEBO_COMPARATOR: Placebo
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).
Normal saline is a cornerstone of intravenous solutions commonly used in the clinical setting. It is a crystalloid fluid administered via an intravenous solution. Its indications include both adult and pediatric populations as sources of hydration and electrolyte disturbances

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Postoperative bleeding
Time Frame: immediately after the surgery
The study parameter is assessed by postoperative chest tube production immediately after the surgery
immediately after the surgery
6-hour postoperative bleeding
Time Frame: within 6-hour after the surgery
The study parameter is asses the accumulation of drain production within 6 hours postoperatively after surgical procedure
within 6-hour after the surgery
24-hour postoperative bleeding
Time Frame: within 24-hour after the surgery
The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure
within 24-hour after the surgery
48-hour postoperative bleeding
Time Frame: within 48-hour after the surgery
The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure
within 48-hour after the surgery
Postoperative blood product transfusion
Time Frame: 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.
participants will be followed for the duration of ICU and intermediate ward stay, an expected average of 5-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Komite Etik Pusat Jantung Nasional Harapan Kita, Ethical Committee of National Cardiovascular Center Harapan Kita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2022

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

January 6, 2023

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study protocol, ethical clearance letter, the primary database of the study, as well as the study's analysis plan and the manuscript of the study will be made available on the permission by the grant provider and ethical committee

IPD Sharing Time Frame

January 6, 2022 for 2 (two) years

IPD Sharing Access Criteria

for peer-reviewing or for further analysis or when needed by authors of a systematic review/meta analysis of randomized controlled trials

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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