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

Phase 2RecruitingNCT06657924

Kristen Ban394 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

394

Conditions

Bleeding Colorectal Disorders Thromboembolism

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Perioperative change in hemoglobin

Preoperative to lowest postoperative within 30 days of surgery

Time frame: 60 days

Secondary Outcomes

Rate of composite bleeding complication

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

Time frame: Within 30 days postop

Rate of composite thromboembolic event

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