Actively Recruiting
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
Led by Kristen Ban · Updated on 2026-05-28
394
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether preoperative use of tranexamic acid (TXA) can reduce bleeding during and after major colorectal surgery. This phase 2 randomized clinical trial is designed to answer key questions about the effects of TXA on blood loss, bleeding complications, and the risk of blood clot-related problems within 30 days after surgery. Participants are randomly assigned to two groups: one receives TXA, given as a 1 gram intravenous bolus in 100 ml saline over 10 minutes at both the start and end of surgery for a total of 2 grams, while the other group receives standard care without TXA. The study compares these approaches to see if TXA affects bleeding and clotting outcomes. During the study, researchers will monitor changes in hemoglobin levels from before surgery to the lowest level within 30 days after surgery. They will also track bleeding complications such as blood transfusions, return to surgery, or death due to bleeding, along with thromboembolic events like stroke, heart attack, deep vein thrombosis, or pulmonary embolism within 30 days. The entire study period includes follow-up to assess these outcomes and ensure patient safety.
CONDITIONS
Brief Title
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
You will not qualify if you...
- Creatinine clearance less than 30 mL/minute
- Long-term dialysis
- Known defective color vision (color blind)
- Pregnancy
- History of venous or arterial thromboembolism, or active thromboembolic disease
- Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo major colorectal surgery during which tranexamic acid or control treatment is administered. Immediate post-operative care follows surgery.
1 visit (in-person)
Duration - Up to 30 days post-surgery
Participants are monitored for bleeding complications and thromboembolic events after surgery.
Follow-up visits as needed within 30 days post-surgery
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
Actively Recruiting
Research Team
K
Kristen A Ban, MD MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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