NCT06657924 Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
| NCT ID | NCT06657924 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kristen Ban |
| Condition | Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 394 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 394 participants in total. It began in 2025-02-11 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Kristen A Ban, MD MS
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06657924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06657924 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06657924 currently recruiting?
Yes, NCT06657924 is actively recruiting participants. Contact the research team at bank4@ccf.org for enrollment information.
Where is the NCT06657924 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06657924 clinical trial?
NCT06657924 is sponsored by Kristen Ban. The principal investigator is Kristen A Ban, MD MS at The Cleveland Clinic. The trial plans to enroll 394 participants.