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Coronary Artery DiseasePhase 4NCT05708690

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

A Phase 4 study testing Tranexamic Acid 100 MG/ML and normal saline in people with Coronary Artery Disease and Valvular Heart Disease, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tranexamic Acid 100 MG/ML and normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
1 siteIndonesia
Study dates
1 Oct 2022to 6 Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • National Cardiovascular Center Harapan Kita

    Jakarta, DKI Jakarta, 11410

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Being tested
Tranexamic Acid 100 MG/ML, normal saline
Keywords
CABG, OPCAB, Heart Valve Surgery, Tranexamic Acid, Postoperative Bleeding, Blood Product Transfusion
Medical subject headings
Coronary Artery Disease, Heart Valve Diseases, Blood Loss, Surgical, Postoperative Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic Acid 100 MG/MLDrug

    Also called Tranexamic Acid

    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 salineDrug

    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

Study groups in NCT05708690
Study groupRoleWhat they receive
Tranexamic Acid TopicalExperimentalThe 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)
Receives: Drug: Tranexamic Acid 100 MG/ML
PlaceboPlacebo comparatorThe 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).
Receives: Drug: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Initial Postoperative bleeding

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

    Measured: immediately after the surgery

  2. 6-hour postoperative bleeding

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

    Measured: within 6-hour after the surgery

  3. 24-hour postoperative bleeding

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

    Measured: within 24-hour after the surgery

  4. 48-hour postoperative bleeding

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

    Measured: within 48-hour after the surgery

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2023
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2022
  4. Study completion6 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05708690
Sponsor's protocol ID
TRACS
Other IDs
1706120543, 1706120530
Status last verified
Jan 2023
First submitted
9 Jan 2023
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 31136475

  • 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.

    PubMed 23881695

  • 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.

    PubMed 30908754

  • 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.

    PubMed 16438759

  • 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.

    PubMed 17218108

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic Acid 100 MG/ML and normal saline in people with Coronary Artery Disease and Valvular Heart Disease, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial Postoperative bleeding (time frame: immediately after the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05708690, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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