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

Phase 2

Recruiting

• Conditions: Bleeding; Colorectal Disorders; Thromboembolism; Tranexamic Acid
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT06657924
• Lead Sponsor: Kristen Ban

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Study Start: 2025-02-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-09-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 394

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	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

Primary Outcome Measures

Name	Time	Method
Perioperative change in hemoglobin	60 days	Preoperative to lowest postoperative within 30 days of surgery

Secondary Outcome Measures

Name	Time	Method
Rate of composite bleeding complication	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
Rate of composite thromboembolic event	Within 30 days postop	Thromboembolic cerebrovascular accident (CVA), myocardial infarction (MI), deep venous thrombosis (DVT), pulmonary embolism (PE)

Trial Locations

Locations (1)

Cleveland Clinic Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States