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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKristen Ban

About this trial

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

Qualifiers

Adults 18 years or older

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

Disqualifiers

Creatinine clearance less than 30 mL/minute

Long-term dialysis

Known defective color vision (color blind)

Pregnancy

Trial design

Treatments tested in this trial

  • Tranexamic acid

Treatment groups

394 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kristen Ban

Lead sponsor

The Cleveland Clinic

Sponsor institution