RecruitingPhase 2NCT06657924

Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery


Sponsor

Kristen Ban

Enrollment

394 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are: * Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days) * Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding) * Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism) Researchers will compare preoperative TXA to no TXA to answer the above questions. Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • Adults 18 years or older
  • Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Exclusion Criteria6

  • Creatinine clearance less than 30 mL/minute
  • Long-term dialysis
  • Known defective color vision (color blind)
  • Pregnancy
  • History of venous or arterial thromboembolism, or active thromboembolic disease
  • Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTranexamic acid

1 gram IV bolus in 100ml of normal saline administered over 10 minutes at the start and end of the surgery for a total of 2 grams TXA


Locations(1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06657924


Related Trials