Actively Recruiting
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
Led by Kristen Ban · Updated on 2025-04-27
394
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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) suspected or confirmed by blood tests
AI-Screening
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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
CONTACT
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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