Breast CancerPhase 4NCT05807074
Impact of Topical Tranexamic Acid in Breast Reconstruction
A Phase 4 study testing Tranexamic Acid and Saline in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tranexamic Acid and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 30 Nov 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast malignancy OR increased risk for breast cancer
- Age >= 18 years
- Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction
- Ability to understand a written informed consent document, and the willingness to sign it
- At least 4 weeks post-completion of chemotherapy or radiation therapy
Who cannot join
- Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
- Any history of thromboembolic disease
- Current anticoagulant use
- Current use of chlorpromazine due to label contraindication
- Current use of any prothrombotic medical products due to label contraindication
- Documented or reported allergic reaction to tranexamic acid
- Male participants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients.
Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.
Read the detailed description
PRIMARY OUTCOMES:
- To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.
II. To evaluate the impact of TXA on seroma rates compared to control.
SECONDARY OUTCOMES:
- To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.
II. To evaluate the impact of TXA on total drain output in the first post operative day.
III. To evaluate the impact of TXA on total drain duration.
OUTLINE:
Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.
- Conditions
- Breast Cancer
- Being tested
- Tranexamic Acid, Saline
- Keywords
- Breast Reconstruction, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA, Lysteda
Applied intraoperatively
SalineOther
Also called Saline solution, Sodium Chloride 0.9%
Applied intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Each participant will have one breast pocket exposed to TXA and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline. Receives: Drug: Tranexamic Acid; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Breast Pockets That Develop a Hematoma
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
Measured: Up to 1 month
Number of Breast Pockets That Develop a Seroma
Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.
Measured: Up to 3 months
Secondary outcomes (5)
Number of Breast Pockets That Developed Ecchymosis
Ecchymosis will be measured separately for the right and left breast pocket at each post operative visit and documented. The observer will be blinded to the laterality of TXA. Both participant and provider will be asked to rank which side, the right or left side, has worse bruising. The frequency of ecchymosis for the right and left side will be reported descriptively.
Measured: Up to 1 year
Median Total Drain Output
Total drain output over the life of the drain from drain placement in the operating room to discharge on post-operation day 1. Drains will be removed per standard practice at our institution which is when they have produced < 30 cubic centimeters (cc) per day for at least 3 days.
Measured: Approximately 1 month
Median Total Drain Duration
The median time of total drain duration from drain placement in the operating room to removal of the drain will be reported descriptively for the saline only and TXA treated breast.
Measured: Approximately 1 month
Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy
The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.
Measured: Up to 1 year
Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy
The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start20 Apr 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: Slow Accrual
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merisa Piper, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807074
- Sponsor's protocol ID
- 228012
- Other IDs
- NCI-2023-02817
- Status last verified
- Aug 2025
- First submitted
- 29 Mar 2023
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery
- ClinicalTrials.gov ID
- NCT05807074
- Acronym / sponsor ID
- 228012
- Conditions
- Breast Cancer
- Keywords
- Breast Reconstruction, Mastectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients.
Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.
Detailed description
PRIMARY OUTCOMES:
- To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.
II. To evaluate the impact of TXA on seroma rates compared to control.
SECONDARY OUTCOMES:
- To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.
II. To evaluate the impact of TXA on total drain output in the first post operative day.
III. To evaluate the impact of TXA on total drain duration.
OUTLINE:
Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: Tranexamic Acid, Other: SalineEach participant will have one breast pocket exposed to TXA and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed breast malignancy OR increased risk for breast cancer
- Age >= 18 years
- Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction
- Ability to understand a written informed consent document, and the willingness to sign it
- At least 4 weeks post-completion of chemotherapy or radiation therapy
Key exclusion criteria (7 listed)
- Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
- Any history of thromboembolic disease
- Current anticoagulant use
- Current use of chlorpromazine due to label contraindication
- Current use of any prothrombotic medical products due to label contraindication
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 AcidAlso: TXA, LystedaApplied intraoperatively | Drug | All participants |
| SalineAlso: Saline solution, Sodium Chloride 0.9%Applied intraoperatively | Other | All participants |
Primary outcome
Number of Breast Pockets That Develop a Hematoma
Time frame: Up to 1 month
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
Number of Breast Pockets That Develop a Seroma
Time frame: Up to 3 months
Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.
5 secondary outcomes
Number of Breast Pockets That Developed Ecchymosis
Time frame: Up to 1 year
Median Total Drain Output
Time frame: Approximately 1 month
Median Total Drain Duration
Time frame: Approximately 1 month
Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy
Time frame: Up to 1 year
Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Merisa Piper, MD principal investigator
University of California, San Francisco
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 and Saline in people with Breast Cancer, run by University of California, San Francisco 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Sep 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 29 Sep 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?
Number of Breast Pockets That Develop a Hematoma (time frame: Up to 1 month). The study lists 2 primary outcomes in all. 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 29 Sep 2025.