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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 394 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | February 11, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT06657924 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.