RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-11
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06657924

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults 18 years or older
  2. 2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
  1. 1. Creatinine clearance less than 30 mL/minute
  2. 2. Long-term dialysis
  3. 3. Known defective color vision (color blind)
  4. 4. Pregnancy
  5. 5. History of venous or arterial thromboembolism, or active thromboembolic disease
  6. 6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Contacts and Locations

Study Contact

Kristen A Ban, MD MS
CONTACT
2164766961
bank4@ccf.org

Principal Investigator

Kristen A Ban, MD MS
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
United States

Collaborators and Investigators

Sponsor: Kristen Ban

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2025-02-11
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • Tranexamic Acid
  • TXA
  • Bleeding
  • Colorectal Surgery
  • Thromboembolism

Additional Relevant MeSH Terms

  • Bleeding
  • Colorectal Disorders
  • Thromboembolism
  • Tranexamic Acid