TXA for Gender Affirming Mastectomy

(IVTXA Trial)

Recruiting at 1 trial location

Overseen By Carolyn Cafro, BS

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Coagulopathy, Thromboembolic events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tranexamic acid (TXA) can reduce bleeding complications in individuals undergoing gender-affirming mastectomy (top surgery). The goal is to determine if TXA lowers the risk of developing hematoma (a collection of blood outside blood vessels) and seroma (fluid build-up). Participants will be randomly assigned to receive TXA or not during surgery to compare outcomes. The trial seeks individuals planning to undergo top surgery at UCSF who have been on hormone therapy for 12 months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant or antiplatelet medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that tranexamic acid (TXA) is generally safe for use in surgeries, including gender-affirming mastectomies. Studies have found that TXA can lower the risk of complications like hematoma (a buildup of blood outside blood vessels) and seroma (a pocket of clear fluid) without increasing the risk of dangerous blood clots. Specifically, one study found no rise in the risk of blood clots in veins or infections among patients who received TXA.

Other research supports these findings, showing that TXA can reduce swelling and bruising and lessen the need for drains after surgery. These benefits make TXA a promising option for those undergoing gender-affirming surgery, as it seems to improve recovery without adding significant safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tranexamic Acid (TXA) is unique because it helps reduce blood loss by preventing the breakdown of blood clots. Unlike the standard care for gender-affirming mastectomy, which typically involves surgical techniques and postoperative management to control bleeding, TXA directly targets the body's clot-dissolving process. Researchers are excited about TXA because it could improve surgical outcomes by minimizing blood loss, leading to quicker recovery and fewer complications. This makes it a promising addition to the surgical care of transgender individuals undergoing mastectomy.

What evidence suggests that tranexamic acid might be an effective treatment for reducing hematoma and seroma in gender affirming mastectomy?

Research has shown that tranexamic acid (TXA) can help reduce post-surgery complications. In this trial, participants in the experimental group will receive TXA during their gender-affirming mastectomy. Studies have found that TXA significantly lowers the chances of fluid buildup (seroma) and bruising (hematoma) compared to those who did not receive it. Specifically, one study found that the rate of fluid buildup dropped from 33% to 20.5%, and the rate of bruising fell from 5.7% to 0.5% with TXA. These findings suggest that TXA can effectively reduce complications after these surgeries. ^{1 2 3 6 7}

Who Is on the Research Team?

Esther Kim, MD

Principal Investigator

UCSF Department of Plastic & Reconstructive Surgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing gender affirming mastectomy at UCSF and meet WPATH guidelines. It's not for those with a history of bleeding disorders, chest surgery, severe kidney issues, or allergies to TXA. Participants must be able to consent and should not have chronic anticoagulation or antiplatelet medication use.

Inclusion Criteria

I had a gender affirming mastectomy at UCSF.

I meet the WPATH standards for gender-affirming surgery, including hormone therapy and mental health stability.

ASA I-III

Exclusion Criteria

I take blood thinners regularly or have had a bad reaction to IV TXA.

I have a history of bleeding disorders or blood clotting issues.

I have had blood clots in my veins or lungs before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gender affirming mastectomy with or without intravenous tranexamic acid (TXA) administration

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for hematoma, seroma, and drain output; standard postoperative care is provided

Up to 3 months

Multiple visits (in-person)

Follow-up

Participants are monitored for long-term outcomes including thromboembolic events and wound complications

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests if intravenous tranexamic acid (IV TXA) can reduce bleeding and fluid collection after gender affirming mastectomy. Patients will be randomly assigned to receive IV TXA or no treatment in this prospective randomized control trial.

How Is the Trial Designed?

Group I: IV TXA Group Experimental Treatment 1 Intervention

Patients in the experimental group will receive a loading dose of IV tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Postoperative care will be standard and based on established UCSF guidelines.

Group II: Control Group Active Control 1 Intervention

Patients in the control group will not receive any IV TXA intraoperatively and will undergo a traditional gender affirming mastectomy following the established standard of care.

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The combination of docetaxel and radiation therapy resulted in partial remission of metastatic tumors in a 68-year-old woman with recurrent breast cancer, indicating its potential efficacy for treating such cases.

Despite experiencing significant side effects like alopecia and neutropenia, the adverse reactions were manageable and reversible, suggesting that this treatment strategy can be safely administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A case of head metastases of breast cancer successfully treated with radiation therapy and docetaxel]. Aotake, T., Horiuchi, T., Yokomachi, J., et al.[2018]

In two cases of advanced metastatic breast cancer, the combination of docetaxel and intra-arterial adriamycin resulted in clinical responses lasting over 20 weeks, indicating potential efficacy of this treatment approach.

The therapy was associated with manageable side effects, including grade 2 leukopenia and alopecia, but no severe grade 4 toxicities, suggesting that it can be safely administered to outpatients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Two cases of advanced and metastatic breast cancers treated by docetaxel in combination with intra-arterial infusion of adriamycin]. Doihara, H., Yoshitomi, S., Hino, M., et al.[2018]

In a study of 260 patients undergoing gender-affirming mastectomies, the periareolar technique was associated with a higher rate of hematomas (12.5% vs. 2.9%) and a greater need for revisionary surgery (15.0% vs. 5.2%) compared to the double-incision method, indicating potential complications with the periareolar approach.

The use of intraoperative liposomal bupivacaine (Exparel) significantly reduced opioid consumption during and after surgery, while the application of tranexamic acid (TXA) did not show any impact on reducing postoperative complications like hematomas or seromas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of enhanced recovery protocols and tranexamic acid on double-incision versus periareolar gender-affirming mastectomy: A retrospective study of postoperative outcomes. Edalatpour, A., Seitz, AJ., Warden, AM., et al.[2023]

The study found that when paclitaxel (TXL) is conjugated to poly(L-glutamic acid) to form PG-TXL, its distribution to tumor tissue is significantly enhanced, with tumor exposure being five times greater compared to TXL administered in a conventional formulation.

PG-TXL maintains a consistent release of free paclitaxel within the tumor over time, which may contribute to its observed antitumor activity in preclinical studies, suggesting a promising mechanism for improving cancer treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodistribution of paclitaxel and poly(L-glutamic acid)-paclitaxel conjugate in mice with ovarian OCa-1 tumor. Li, C., Newman, RA., Wu, QP., et al.[2017]

In a study of 74 breast reduction patients who received intravenous tranexamic acid (TXA) during surgery, there was a significant reduction in postoperative bleeding complications, with only 1.4% experiencing bleeding compared to 16.2% in the control group.

The use of TXA was found to be safe, as there were no significant differences in other complications such as seroma, wound healing issues, or infections, indicating that TXA effectively minimizes hematoma rates without increasing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Usage of Intravenous Tranexamic Acid in Reduction Mammaplasty Safely Reduces Hematoma Rates. Om, A., Marxen, T., Kebede, S., et al.[2023]

Intraoperative administration of tranexamic acid (TXA) during gender-affirming mastectomy significantly reduced the rates of postoperative seroma (20.5% vs. 33.0%) and hematoma (0.5% vs. 5.7%) compared to patients who did not receive TXA, based on a study of 851 patients.

The use of TXA did not increase the risk of venous thromboembolism or surgical-site infections, indicating that it is a safe option for minimizing blood loss and complications in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Tranexamic Acid in Gender-Affirming Mastectomy Reduces Rates of Postoperative Hematoma and Seroma. Rifkin, WJ., Parker, A., Bluebond-Langner, R.[2023]

A systematic review of five studies involving 1139 patients showed that perioperative administration of tranexamic acid (TXA) significantly reduces the risk of hematoma (7.3% vs. 12.9%) and seroma formation (11.5% vs. 19.9%) in breast surgery.

The use of TXA did not increase the risk of thromboembolic events or postoperative infections, indicating it is a safe option for patients undergoing breast surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Use in Breast Surgery: A Systematic Review and Meta-Analysis. Liechti, R., van de Wall, BJM., Hug, U., et al.[2023]

Weekly administration of paclitaxel (80 mg/m2) was effective in treating metastatic breast cancer in two cases, leading to the disappearance of metastatic lymph nodes and lesions within 3 months.

The treatment was well-tolerated, with only mild toxic effects such as grade 1 leukopenia and peripheral neuropathy, indicating a favorable safety profile for outpatient administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Two cases of effective weekly paclitaxel administration for metastatic breast cancer]. Kokufu, I., Taniguchi, H., Kim, Y., et al.[2015]

PG-TXL, a drug conjugate with polymeric carriers, significantly enhances the effectiveness of radiotherapy in treating ovarian tumors, reducing the radiation dose needed for tumor control by a factor of 7.2 for single doses and 8.4 for fractionated doses.

Importantly, PG-TXL does not increase damage to normal tissues during radiation treatment, suggesting it can improve the therapeutic ratio of radiotherapy without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poly(L-glutamic acid)-paclitaxel conjugate is a potent enhancer of tumor radiocurability. Milas, L., Mason, KA., Hunter, N., et al.[2019]

Tranexamic acid (TXA) significantly reduces perioperative blood loss in total shoulder arthroplasty (TSA), with a notable decrease in hemoglobin change, drain output, and total blood loss, particularly after reverse TSA, based on a meta-analysis of 6 studies involving 680 patients.

While TXA shows a trend towards reducing transfusion rates after reverse TSA, it did not significantly affect transfusion rates after anatomic TSA, indicating a need for further research to clarify its efficacy in different TSA types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis. Box, HN., Tisano, BS., Khazzam, M.[2022]

In a study of 71,174 shoulder arthroplasty patients, tranexamic acid (TXA) significantly reduced the need for blood transfusions without increasing the risk of complications, even in patients with a history of thrombotic events.

TXA use in patients with a history of thrombotic events was associated with a reduction in hospitalization costs, suggesting it is a safe and effective option for managing blood loss in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of tranexamic acid during total shoulder arthroplasty is not associated with increased risk of complications in patients with a history of thrombotic events. Carbone, A., Poeran, J., Zubizarreta, N., et al.[2021]

In a study of 81 patients undergoing breast reduction, the use of local tranexamic acid (TXA) did not significantly reduce intraoperative blood loss or operative time compared to standard procedures without TXA.

However, the TXA group experienced lower rates of T-junction dehiscence and suture granulomas, suggesting that TXA may enhance safety without increasing overall complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid in Breast Reduction for Symptomatic Macromastia. Nichols, G., Andrade, E., Gregoski, M., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37399532/

Use of Tranexamic Acid in Gender-Affirming Mastectomy ... Patients who received TXA had significantly lower rates of seroma (20.5% versus 33.0%; P < 0.001) and hematoma (0.5% versus 5.7%; P = 0.002).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525000567

Efficacy of topical tranexamic acid in gender-affirming ... This study found no statistically significant differences in postoperative bleeding complication rates between patients who received TXA and those who followed ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38061259/

Outcomes of enhanced recovery protocols and tranexamic ... Outcomes of enhanced recovery protocols and tranexamic acid on double-incision versus periareolar gender-affirming mastectomy: A retrospective study of ...

4. journals.lww.com journals.lww.com/prsgo/fulltext/2025/10005/the_impact_of_tranexamic_acid_use_in.21.aspx

The Impact of Tranexamic Acid Use in Gender-Affirming... The TXA cohort had a lower rate of hematoma (1.8% versus 2.3%, respectively; p=0.4) and seroma (0.8% versus 1.4%, respectively; p=0.1) but with no significant ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681523007453

A retrospective study of postoperative outcomes Outcomes of enhanced recovery protocols and tranexamic acid on double-incision versus periareolar gender-affirming mastectomy: A retrospective study of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9592459/

Use of Tranexamic Acid in Gender-affirming Mastectomy These studies demonstrate decreased edema and ecchymosis, as well as reduced rates of postoperative collections with administration of TXA, ...

7. meeting.nesps.org meeting.nesps.org/program/2023/80.cgi

Use of Tranexamic Acid in Gender-Affirming Mastectomy ... Intraoperative administration of TXA in patients undergoing top surgery may safely reduce the risk of postoperative seroma and hematoma without increased risk ...