NCT06657924

Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: Kristen Ban · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bleeding
• Colorectal Disorders
• Thromboembolism
• Tranexamic Acid

Interventions

Type	Name	Description
DRUG	Tranexamic acid	1 gram IV bolus in 100ml of normal saline administered over 10 minutes at the start and end of the surgery for a total of 2 grams TXA

Timeline

• Start date: 2025-02-11
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2024-10-26
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study