Hematoma PostoperativePhase 4NCT05441592
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
A Phase 4 study testing Tranexamic acid injection and No additional irrigation in people with Hematoma Postoperative, run by University of Michigan at 1 site in United States.
Trial summary
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma Postoperative
- What is being tested?
- Tranexamic acid injection and No additional irrigation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 22 Oct 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
- For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
- For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
Who cannot join
- Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
- Current use of systemic anticoagulation
- Hypersensitivity to tranexamic acid
- Concomitant use of combined hormonal contraceptives
- Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
- History of acquired defective color vision
Show all 9Show fewer
- History of subarachnoid hemorrhage
- Pregnancy
- History of renal impairment or serum Creatinine >1.5 milligrams per deciliter (mg/dL)
Trial locations and contacts
1 site in 1 country.
About this study
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
- Conditions
- Hematoma Postoperative
- Being tested
- Tranexamic acid injection, No additional irrigation
- Keywords
- Breast reduction, Gender-affirming mastectomy, Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
No additional irrigationOther
There will be no additional irrigation after the standard surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation that contains tranexamic acid (TXA) | Experimental | Not described Receives: Drug: Tranexamic acid injection |
| No additional irrigation usual care | Other | Not described Receives: Other: No additional irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematomas
Results reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.
Measured: Up to approximately 4 weeks after surgery
Secondary outcomes (2)
Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug
Results reflect the number of participants who experienced any major thromboembolic event during the trial. Major thromboembolic events included, but were not limited to, deep vein thrombosis, pulmonary embolism, and stroke.
Measured: Up to approximately 4 weeks after surgery
Participants Who Experienced Major Complications Other Than Hematoma
Results reflect the number of participants who experienced any major complication other than a hematoma. Major complications included, but were not limited to, infection, seroma, hypersensitivity reaction to TXA, and renal impairment.
Measured: Up to approximately 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start15 Aug 2022
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematoma PostoperativeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin G. Wilkins, University of Michigan
- Investigators
- Edwin Wilkins, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441592
- Sponsor's protocol ID
- HUM00210979
- Status last verified
- Oct 2025
- First submitted
- 27 Jun 2022
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
- ClinicalTrials.gov ID
- NCT05441592
- Acronym / sponsor ID
- HUM00210979
- Conditions
- Hematoma Postoperative
- Keywords
- Breast reduction, Gender-affirming mastectomy, Tranexamic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation that contains tranexamic acid (TXA) | Experimental | Drug: Tranexamic acid injection |
| No additional irrigation usual care | Other | Other: No additional irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
- For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
- For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
Key exclusion criteria (9 listed)
- Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
- Current use of systemic anticoagulation
- Hypersensitivity to tranexamic acid
- Concomitant use of combined hormonal contraceptives
- Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
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 acid injectionThe breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes. | Drug | Irrigation that contains tranexamic acid (TXA) |
| No additional irrigationThere will be no additional irrigation after the standard surgical procedure. | Other | No additional irrigation usual care |
Primary outcome
Hematomas
Time frame: Up to approximately 4 weeks after surgery
Results reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.
2 secondary outcomes
Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug
Time frame: Up to approximately 4 weeks after surgery
Participants Who Experienced Major Complications Other Than Hematoma
Time frame: Up to approximately 4 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Edwin Wilkins, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid injection and No additional irrigation in people with Hematoma Postoperative, run by University of Michigan 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 26 Nov 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematomas (time frame: Up to approximately 4 weeks after surgery). 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 26 Nov 2025.