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NCT Number: NCT06657924

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

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.

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Key information

Conditions

Bleeding Cardiovascular Diseases Colorectal Disorders Embolism and Thrombosis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Tranexamic Acid Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location status: Recruiting

Location contact

Kristen A Ban, MD MS

CONTACT

[email protected]

2164766961

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18 years or older
  • Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Exclusion criteria

  • Creatinine clearance less than 30 mL/minute
  • Long-term dialysis
  • Known defective color vision (color blind)
  • Pregnancy
  • History of venous or arterial thromboembolism, or active thromboembolic disease
  • Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Treatment and study plan

Tranexamic Acid

Drug

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

Primary outcomes

  1. Perioperative change in hemoglobin

    Time frame: 60 days

    Preoperative to lowest postoperative within 30 days of surgery

Secondary outcomes

  1. Rate of composite bleeding complication

    Time frame: Within 30 days postop

    Bleeding requiring transfusion, bleeding prompting medication to be held for DVT prophylaxis or therapeutic anticoagulation, bleeding requiring return to the operating room or procedural intervention, mortality secondary to bleeding

  2. Rate of composite thromboembolic event

    Time frame: Within 30 days postop

    Thromboembolic cerebrovascular accident (CVA), myocardial infarction (MI), deep venous thrombosis (DVT), pulmonary embolism (PE)

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen A Ban, MD MS

CONTACT

[email protected]

2164766961

Sponsors and collaborators

Lead sponsor

Kristen Ban

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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