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

NCT05708690 | Completed Phase 4

• 3 other identifiers: TRACS17061205431706120530
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Surgical Blood Loss

Keywords

CABG; OPCAB; Heart Valve Surgery; Tranexamic Acid; Postoperative Bleeding; Blood Product Transfusion

Outcome Measures

Primary Outcomes (5)

• Initial Postoperative bleeding

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

  immediately after the surgery

• 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

• 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

• 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

• 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

Study Arms (2)

Tranexamic Acid Topical

EXPERIMENTAL

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)

Drug: Tranexamic Acid 100 MG/ML

Placebo

PLACEBO COMPARATOR

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).

Drug: normal saline

Interventions

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

Also known as: Tranexamic Acid

Tranexamic Acid Topical

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11410, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 31136475 BACKGROUND

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

  PMID: 23881695 BACKGROUND

• 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 Surg. 2019 May;34(5):305-311. doi: 10.1111/jocs.14027. Epub 2019 Mar 25.

  PMID: 30908754 RESULT

• 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.

  PMID: 16438759 RESULT

• 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 371. doi: 10.1016/j.ejcts.2006.12.003. Epub 2007 Jan 10.

  PMID: 17218108 RESULT

MeSH Terms

Conditions

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

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Komite Etik Pusat Jantung Nasional Harapan Kita

  Ethical Committee of National Cardiovascular Center Harapan Kita

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects were not aware of the arms/treatment given as they were under general anesthesia during the application of interventions being studied. Besides, during the informed consent for the elective cardiac surgery, subjects were extensively given explanation of the purpose, methods, benefits and risks of the procedure including the randomized nature of the allocation to either arms of the study. Principal investigators as well as outcomes assessor were kept unaware of the randomization of interventions as they both were restricted for assessing the patients' medical record and the patient identity were coded in the primary database.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.dr.Dudy Arman Hanafy, Sp.BTKV(K)-D, MARS

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 1, 2023
• Study Start: October 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 6, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: January 6, 2022 for 2 (two) years
• Access Criteria: for peer-reviewing or for further analysis or when needed by authors of a systematic review/meta analysis of randomized controlled trials

Locations

ID (1)