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

Primary Purpose

Coronary Artery Disease, Valvular Heart Disease, Surgical Blood Loss

Status

Completed

Phase

Phase 4

Locations

Indonesia

Study Type

Interventional

Intervention

Tranexamic Acid 100 MG/ML

normal saline

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, OPCAB, Heart Valve Surgery, Tranexamic Acid, Postoperative Bleeding, Blood Product Transfusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cardiovascular Center Harapan Kita

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid Topical

Placebo

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

Initial Postoperative bleeding

The study parameter is assessed by postoperative chest tube production 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

24-hour postoperative bleeding

The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure

48-hour postoperative bleeding

The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05708690

First Posted

January 9, 2023

Last Updated

January 31, 2023

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT05708690

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

January 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Valvular Heart Disease, Surgical Blood Loss

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic Acid Topical

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid 100 MG/ML

Other Intervention Name(s)

Tranexamic Acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

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 Outcome Measure Information:

Title

Initial Postoperative bleeding

Description

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

Time Frame

immediately after the surgery

Title

6-hour postoperative bleeding

Description

The study parameter is asses the accumulation of drain production within 6 hours postoperatively after surgical procedure

Time Frame

within 6-hour after the surgery

Title

24-hour postoperative bleeding

Description

The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure

Time Frame

within 24-hour after the surgery

Title

48-hour postoperative bleeding

Description

The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure

Time Frame

within 48-hour after the surgery

Title

Postoperative blood product transfusion

Description

The amount of red blood cell, fresh frozen plasma, thrombocyte concentrate, and cryoprecipitate transfusions the patient receive postoperatively during their stay in the hospital.

Time Frame

participants will be followed for the duration of ICU and intermediate ward stay, an expected average of 5-7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Komite Etik Pusat Jantung Nasional Harapan Kita

Organizational Affiliation

Ethical Committee of National Cardiovascular Center Harapan Kita

Official's Role

Study Chair

Facility Information:

Facility Name

National Cardiovascular Center Harapan Kita

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

11410

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

31136475

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.

Results Reference

background

PubMed Identifier

23881695

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.

Results Reference

background

PubMed Identifier

30908754

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

Results Reference

result

PubMed Identifier

16438759

Citation

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.

Results Reference

result

PubMed Identifier

17218108

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

Results Reference

result

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

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