Clinical trial NCT05994989: Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery
Official title: The Effect of Two Different Tranexamic Acid Dose Regimens on Intraoperative and Postoperative Bleeding in Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Hemorrhage
Keywords: Tranexamic acid
Coronary artery bypass
Hemorrhage
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have coronary artery disease requiring coronary artery bypass surgery with cardiopulmonary bypass

Brief summary: The primary aim of this study is to observe the effects of two different methods of administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively in cardiovascular surgery, on patients' postoperative bleeding amounts. According to the hypothesis established in this study, it is anticipated that administering tranexamic acid as an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable blood level compared to the sole i.v. bolus application, thereby being more effective in influencing postoperative bleeding levels.

The study has been designed as a prospective observational research. The outcomes of two different tranexamic acid protocols applied during cardiovascular surgical procedures will be compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration.

The cases collected over a period of 14 months will be divided into two groups and compared in terms of intraoperative and postoperative bleeding levels, as well as their need for blood products.


Eligibility criteria: Inclusion Criteria:

* Patients who have coronary artery disease requiring coronary artery bypass surgery with cardiopulmonary bypass and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study.
* Writen consent obtained

Exclusion Criteria:

* Patients operated on for reasons other than coronary artery bypass surgery
* Patients who operated on as emergencies
* Patients who have preoperative liver/renal dysfunction or a history of cerebrovascular events
* Patients under the age of 18
* Patients who have coagulation disorder
* Patients who have a history of allergies
* Pregnancy or lactation
* Disabled in spirit or law

Primary outcomes:
measure: Postoperative hemorrhage
timeFrame: Postoperative 1st, 6th and 24th hours
Secondary outcomes:
measure: Postoperative hemorrhage
timeFrame: Postoperative first 24 hours
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Gazi Yaşargil Education and Research Hospital
Study officials:
References:
citation: Guo J, Gao X, Ma Y, Lv H, Hu W, Zhang S, Ji H, Wang G, Shi J. Different dose regimes and administration methods of tranexamic acid in cardiac surgery: a meta-analysis of randomized trials. BMC Anesthesiol. 2019 Jul 15;19(1):129. doi: 10.1186/s12871-019-0772-0.
citation: Zhou ZF, Zhai W, Yu LN, Sun K, Sun LH, Xing XF, Yan M. Comparison of the in-vivo effect of two tranexamic acid doses on fibrinolysis parameters in adults undergoing valvular cardiac surgery with cardiopulmonary bypass - a pilot investigation. BMC Anesthesiol. 2021 Feb 2;21(1):33. doi: 10.1186/s12871-021-01234-8.
citation: Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Extra Corpor Technol. 2021 Jun;53(2):97-124. doi: 10.1182/ject-2100053. No abstract available.
citation: Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.
citation: Madathil T, Balachandran R, Kottayil BP, Sundaram KR, Nair SG. Comparison of efficacy of two different doses of tranexamic acid in prevention of post operative blood loss in patients with congenital cyanotic heart disease undergoing cardiac surgery. Ann Card Anaesth. 2021 Jul-Sep;24(3):339-344. doi: 10.4103/aca.ACA_162_20.