- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708690
Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery
January 31, 2023 updated by: Dudy Arman Hanafy, Sp. BTKV (K), MARS, Indonesia University
Topical Application 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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 11410
- National Cardiovascular Center Harapan Kita
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tranexamic Acid Topical
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)
|
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:
|
PLACEBO_COMPARATOR: Placebo
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).
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial Postoperative bleeding
Time Frame: immediately after the surgery
|
The study parameter is assessed by postoperative chest tube production immediately after the surgery
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immediately after the surgery
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6-hour postoperative bleeding
Time Frame: within 6-hour after the surgery
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The study parameter is asses the accumulation of drain production within 6 hours postoperatively after surgical procedure
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within 6-hour after the surgery
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24-hour postoperative bleeding
Time Frame: within 24-hour after the surgery
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The study parameter is asses the accumulation of drain production within 24 hours postoperatively after surgical procedure
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within 24-hour after the surgery
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48-hour postoperative bleeding
Time Frame: within 48-hour after the surgery
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The study parameter is asses the accumulation of drain production within 48 hours postoperatively after surgical procedure
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within 48-hour after the surgery
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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
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The amount of red blood cell, fresh frozen plasma, thrombocyte concentrate, and cryoprecipitate transfusions the patient receive postoperatively during their stay in the hospital.
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participants will be followed for the duration of ICU and intermediate ward stay, an expected average of 5-7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Komite Etik Pusat Jantung Nasional Harapan Kita, Ethical Committee of National Cardiovascular Center Harapan Kita
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2022
Primary Completion (ACTUAL)
December 31, 2022
Study Completion (ACTUAL)
January 6, 2023
Study Registration Dates
First Submitted
January 9, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (ACTUAL)
February 1, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Postoperative Complications
- Coronary Disease
- Intraoperative Complications
- Heart Diseases
- Coronary Artery Disease
- Hemorrhage
- Heart Valve Diseases
- Blood Loss, Surgical
- Postoperative Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- TRACS
- 1706120543 (OTHER: FKUI - harapan kita national heart center)
- 1706120530 (OTHER: FKUI - harapan kita national heart center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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