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NCT Number: NCT05708690

Topical 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Blood Loss, Surgical Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Hemorrhage Intraoperative Complications Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Surgical Blood Loss Valvular Heart Disease Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11410, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid 100 MG/ML

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Initial Postoperative bleeding

    Time frame: immediately after the surgery

    The study parameter is assessed by postoperative chest tube production immediately after the surgery

  2. 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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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