Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 100

Using tranexamic acid to reduce bleeding in major colorectal surgery

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

Run by The Cleveland Clinic · NCT06657924 · Data updated 2026-11-12

This study is testing if giving tranexamic acid before major colorectal surgery can help reduce bleeding during and after the operation for patients.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment394 (estimated)
SponsorThe Cleveland Clinic
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedFebruary 11, 2025
Main results expectedSeptember 1, 2027
Study endsOctober 1, 2027
Registry record updatedMay 28, 2026
Trial IDNCT06657924 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older who are scheduled for elective or non-elective inpatient abdominal and pelvic colorectal surgery.

Probably not a fit

Patients with severe renal impairment, a history of thromboembolic disease, or those who are pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of preoperative tranexamic acid (TXA) in reducing bleeding during and after major colorectal surgery. It is a prospective, pragmatic, randomized trial comparing patients receiving TXA to those who do not. The study will measure changes in hemoglobin levels and the incidence of bleeding complications within 30 days post-surgery, while also assessing any potential increase in thromboembolic events. Participants will receive TXA intravenously at the start and end of their surgical procedure.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of bleeding complications in patients undergoing major colorectal surgery.

How similar studies have gone: Previous studies have shown promising results with the use of tranexamic acid in various surgical settings, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Adults 18 years or older
2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

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 confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Where it's running

  • Cleveland Clinic Fairview Hospital
    Cleveland, Ohio, United States
    Recruiting

Study contacts

  • Principal investigator: Kristen A Ban, MD MS — The Cleveland Clinic
  • Study coordinator: Kristen A Ban, MD MS
  • Email: bank4@ccf.org
  • Phone: 2164766961

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.