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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05708690
• Other study ID #: TRACS
• Secondary ID: 1706120543170612
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: January 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 6, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Hemorrhage
• Postoperative Hemorrhage
• Surgical Blood Loss
• Valvular Heart Disease

Intervention

Drug:
• Tranexamic Acid 100 MG/ML
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
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

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol. 2006 May;23(5):380-4. doi: 10.1017/S0265021505001894. Epub 2006 Jan 27. — View Citation

Ausen K, Pleym H, Liu J, Hegstad S, Nordgard HB, Pavlovic I, Spigset O. Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1169e-1178e. doi: 10.1097/PRS.0000000000005620. — View Citation

Baric D, Biocina B, Unic D, Sutlic Z, Rudez I, Vrca VB, Brkic K, Ivkovic M. Topical use of antifibrinolytic agents reduces postoperative bleeding: a double-blind, prospective, randomized study. Eur J Cardiothorac Surg. 2007 Mar;31(3):366-71; discussion 37 — View Citation

Habbab LM, Hussain S, Power P, Bashir S, Gao P, Semelhago L, VanHelder T, Parry D, Chu V, Lamy A. Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) study: Results of a pilot study. J Card S — View Citation

Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;(7):CD010562. doi: 10.1002/14651858.CD010562.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial Postoperative bleeding	The study parameter is assessed by postoperative chest tube production immediately after the surgery	immediately after the surgery
Primary	6-hour postoperative bleeding	The study parameter is asses the accumulation of drain production within 6 hours postoperatively after surgical procedure	within 6-hour after the surgery
Primary	24-hour postoperative bleeding	The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure	within 24-hour after the surgery
Primary	48-hour postoperative bleeding	The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure	within 48-hour after the surgery
Primary	Postoperative blood product transfusion	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