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

NCT06657924 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB 24-896
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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

Keywords

Tranexamic Acid; TXA; Bleeding; Colorectal Surgery; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Perioperative change in hemoglobin

  Preoperative to lowest postoperative within 30 days of surgery

  60 days

Secondary Outcomes (2)

• Rate of composite bleeding complication

  Within 30 days postop

• Rate of composite thromboembolic event

  Within 30 days postop

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic acid

Control (no tranexamic acid)

NO INTERVENTION

Standard of care

Interventions

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

Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kristen Ban: lead

Study Sites (1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Thromboembolism

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Kristen A Ban, MD MS

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen A Ban, MD MS

CONTACT

2164766961; bank4@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Pragmatic (non-blinded)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Intervention (TXA) and control (no TXA) cohorts

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)