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

Last updated: May 27, 2026
Sponsor: Kristen Ban
Overall Status: Active - Recruiting

Phase

2

Condition

Hemorrhage

Hemorrhoids

Thromboembolism

Treatment

Tranexamic acid

Clinical Study ID

NCT06657924
IRB 24-896
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Adults 18 years or older

  2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectalsurgery

Exclusion

Exclusion Criteria:

  1. Creatinine clearance less than 30 mL/minute

  2. Long-term dialysis

  3. Known defective color vision (color blind)

  4. Pregnancy

  5. History of venous or arterial thromboembolism, or active thromboembolic disease

  6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmedby platelet count on CBC, fibrinogen, INR and PTT.

Study Design

Total Participants: 394
Treatment Group(s): 1
Primary Treatment: Tranexamic acid
Phase: 2
Study Start date:
February 11, 2025
Estimated Completion Date:
October 01, 2027

Connect with a study center

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

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