Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery
Condition: Coronary Artery Disease; Valvular Heart Disease; Surgical Blood Loss
MeSH terms: Coronary Artery Disease; Heart Diseases; Heart Valve Diseases; Hemorrhage; Postoperative Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Tranexamic Acid 100 MG/ML; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): Tranexamic Acid
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, single center, parallel phase 4 randomized clinical trial was conducted with two intervention arms: an intervention arm with the use of tranexamic acid topical and a control arm with the use of normal saline in which the subjects' recruitment and treatment were conducted simultaneously by means of a block randomization.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CABG; OPCAB; Heart Valve Surgery; Tranexamic Acid; Postoperative Bleeding; Blood Product Transfusion