Clinical trial NCT05708690: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Valvular Heart Disease
Surgical Blood Loss
Keywords: CABG
OPCAB
Heart Valve Surgery
Tranexamic Acid
Postoperative Bleeding
Blood Product Transfusion
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Initial Postoperative bleeding
timeFrame: immediately after the surgery
measure: 6-hour postoperative bleeding
timeFrame: within 6-hour after the surgery
measure: 24-hour postoperative bleeding
timeFrame: within 24-hour after the surgery
measure: 48-hour postoperative bleeding
timeFrame: within 48-hour after the surgery
measure: Postoperative blood product transfusion
timeFrame: participants will be followed for the duration of ICU and intermediate ward stay, an expected average of 5-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
state: DKI Jakarta
Study officials:
affiliation: Ethical Committee of National Cardiovascular Center Harapan Kita
name: Komite Etik Pusat Jantung Nasional Harapan Kita
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.
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.