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Completed

NCT Number: NCT05994989

Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi Yaşargil Education and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative hemorrhage

    Time frame: Postoperative 1st, 6th and 24th hours

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

Secondary outcomes

  1. Postoperative hemorrhage

    Time frame: Postoperative first 24 hours

    The amounts of blood and blood products administered within the first 24 hours of postoperative

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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