BleedingPhase 2NCT06657924
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
A Phase 2 study testing Tranexamic acid in people with Bleeding and Colorectal Disorders, run by Kristen Ban at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bleeding, Colorectal Disorders, Thromboembolism
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Kristen A Ban, MD MS, 2164766961, bank4@ccf.org
About this study
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)
Read more
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
- Being tested
- Tranexamic acid
- Keywords
- Tranexamic Acid, TXA, Bleeding, Colorectal Surgery, Thromboembolism
- Medical subject headings
- Hemorrhage, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tranexamic acid |
| Control (no tranexamic acid) | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative change in hemoglobin
Preoperative to lowest postoperative within 30 days of surgery
Measured: 60 days
Secondary outcomes (2)
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
Measured: Within 30 days postop
Rate of composite thromboembolic event
Thromboembolic cerebrovascular accident (CVA), myocardial infarction (MI), deep venous thrombosis (DVT), pulmonary embolism (PE)
Measured: Within 30 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start11 Feb 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention (TXA) and control (no TXA) cohorts
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristen Ban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristen Ban, The Cleveland Clinic
- Investigators
- Kristen A Ban, MD MS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657924
- Sponsor's protocol ID
- IRB 24-896
- Status last verified
- May 2026
- First submitted
- 23 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
- ClinicalTrials.gov ID
- NCT06657924
- Acronym / sponsor ID
- IRB 24-896
- Conditions
- Bleeding, Colorectal Disorders, Thromboembolism, Tranexamic Acid
- Keywords
- Tranexamic Acid, TXA, Bleeding, Colorectal Surgery, Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Kristen BanUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention (TXA) and control (no TXA) cohorts
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic acidTXA 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 |
| Control (no tranexamic acid) | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years or older
- Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid1 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 |
Primary outcome
Perioperative change in hemoglobin
Time frame: 60 days
Preoperative to lowest postoperative within 30 days of surgery
2 secondary outcomes
Rate of composite bleeding complication
Time frame: Within 30 days postop
Rate of composite thromboembolic event
Time frame: Within 30 days postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen A Ban, MD MS principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid in people with Bleeding and Colorectal Disorders, run by Kristen Ban at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen A Ban, MD MS (2164766961, bank4@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative change in hemoglobin (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.