Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery

NCT05994989 | Completed

• 1 other identifier: 5.26.2023/408
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Hemorrhage

Keywords

Tranexamic acid; Coronary artery bypass; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Postoperative hemorrhage

  The amount of bleeding within the first 24 hours postoperatively will be compared.

  Postoperative 1st, 6th and 24th hours

Secondary Outcomes (1)

• Postoperative hemorrhage

  Postoperative first 24 hours

Study Arms (2)

Group 1

Patients who have undergone coronary artery bypass surgery and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study. The cases collected over a period of 6 months will be divided into two groups and 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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have coronary artery disease requiring coronary artery bypass surgery with cardiopulmonary bypass

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Gazi Yaşargil Education and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31307381 BACKGROUND

• 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.

  PMID: 33530942 BACKGROUND

• 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.

  PMID: 34194077 BACKGROUND

• 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.

  PMID: 29029990 BACKGROUND

• 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.

  PMID: 34269265 BACKGROUND

MeSH Terms

Conditions

Postoperative Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: August 14, 2023
• Primary Completion: October 14, 2024
• Study Completion: October 21, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

TU (1)