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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Kristen Ban
Study ID
NCT06657924
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bleeding
  • Colorectal Disorders
  • Thromboembolism
  • Tranexamic Acid

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
May 2026
Primary completion
Sep 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
394 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Perioperative change in hemoglobin [ Time Frame: 60 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Fairview HospitalClevelandOhio44111
Kristen A Ban, MD MS
[email protected]
2164766961

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Fairview Hospital· Cleveland, OH

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