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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Bleeding
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States, 44111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adults 18 years or older
  • 2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
  • 1. Creatinine clearance less than 30 mL/minute
  • 2. Long-term dialysis
  • 3. Known defective color vision (color blind)
  • 4. Pregnancy
  • 5. History of venous or arterial thromboembolism, or active thromboembolic disease
  • 6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kristen Ban,

Kristen A Ban, MD MS, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2026-10-01