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

ConditionsBleedingColorectal DisordersThromboembolismTranexamic Acid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKristen Ban

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years or older

Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Disqualifiers

Creatinine clearance less than 30 mL/minute

Long-term dialysis

Known defective color vision (color blind)

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

394 Participants
are divided into 2 treatment groups
Group A: Tranexamic AcidExperimental treatment 1 intervention
Group B: Control (no tranexamic acid)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Perioperative change in hemoglobin

Preoperative to lowest postoperative within 30 days of surgery

Time frame
60 days

Secondary outcomes

1

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
2

Rate of composite thromboembolic event

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

Time frame
Within 30 days postop

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kristen Ban

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
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