NCT05994989

Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery

The Effect of Two Different Tranexamic Acid Dose Regimens on Intraoperative and Postoperative Bleeding in Coronary Artery Bypass Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2023-08-14
• Primary completion: 2024-10-14
• Completion: 2024-10-21
• First posted: 2023-08-16
• Last updated: 2024-12-09

Locations

1 site across 1 country: Turkey (Türkiye)