Recruiting
Phase 2

Tranexamic Acid

Sponsor:

Kristen Ban

Code:

NCT06657924

Conditions

Bleeding

Colorectal Disorders

Thromboembolism

Tranexamic Acid

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid

Study Details

Brief 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.

Conditions

Bleeding

Colorectal Disorders

Thromboembolism

Tranexamic Acid

Study ID

NCT06657924

Start date

Feb 11, 2025

Status verified date

May, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults 18 years or older
2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Exclusion Criteria:

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.

Study Design

Enrollment

394 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

Tranexamic acid

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 outcome measure

  • Perioperative change in hemoglobin [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Kristen A Ban, MD MS

2164766961bank4@ccf.org

Locations

Cleveland Clinic Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Kristen A Ban, MD MS

2164766961bank4@ccf.org

More Information

Sponsor

Kristen Ban

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kristen Ban on 2026-05-28.