Using tranexamic acid to reduce bleeding in major colorectal surgery
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
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 |
| Enrollment | 394 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06657924 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for elective or non-elective inpatient abdominal and pelvic colorectal surgery.
Not a fit: Patients with severe renal impairment, a history of thromboembolic disease, or those who are pregnant may not benefit from this study.
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 performed: Previous studies have shown promising results with the use of tranexamic acid in various surgical settings, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.