ClinicalTrials.gg
RecruitingNCT06657924Updated May 28, 2026

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

A Phase 2 interventional study of Tranexamic acid in Bleeding, Colorectal Disorders and Thromboembolism, sponsored by Kristen Ban. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Kristen Ban · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
394
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bleeding
  • Colorectal Disorders
  • Thromboembolism
  • Tranexamic Acid

Keywords

  • Tranexamic Acid
  • TXA
  • Bleeding
  • Colorectal Surgery
  • Thromboembolism
03

In context

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

This study's planned enrollment of 394 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Kristen Ban as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults 18 years or older
  2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Exclusion criteria

Exclusion Criteria:

  1. 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 count on CBC, fibrinogen, and PTT.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
394 participants (estimated)

Study 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

    Drug: Tranexamic acid

  • No intervention
    Control (no tranexamic acid)

    Standard of care

Interventions

  • 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06657924
Lead sponsor
Kristen Ban
Responsible party
Kristen Ban (Assistant Professor of Surgery, The Cleveland Clinic) — Sponsor-investigator
First posted
Oct 26, 2024
Start date
Feb 11, 2025
Primary completion
Sep 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
May 28, 2026

Study contacts

Kristen A Ban, MD MS
Contact
bank4@ccf.org
2164766961
Kristen A Ban, MD MS
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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