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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Adults 18 years or older

• Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Locations
United States
Ohio
Cleveland Clinic Fairview Hospital
RECRUITING
Cleveland
Contact Information
Primary
Kristen A Ban, MD MS
bank4@ccf.org
2164766961
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 394
Treatments
Experimental: Tranexamic Acid
TXA administered as a 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
No_intervention: Control (no tranexamic acid)
Standard of care
Sponsors
Leads: Kristen Ban

This content was sourced from clinicaltrials.gov