Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery

Completed

• Conditions: Postoperative Hemorrhage

• Registration Number: NCT05994989
• Lead Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-08
• Study Start: 2023-08-14
• Study First Posted: 2023-08-16
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative hemorrhage	Postoperative 1st, 6th and 24th hours	The amount of bleeding within the first 24 hours postoperatively will be compared.

Secondary Outcome Measures

Name	Time	Method
Postoperative hemorrhage	Postoperative first 24 hours	The amounts of blood and blood products administered within the first 24 hours of postoperative

Trial Locations

Locations (1)

Gazi Yaşargil Education and Research Hospital; 🇹🇷 Diyarbakır, Turkey