Topical Tranexamic Acid for Reducing Hematoma Risk in Breast Surgery

Overseen By Sherry Tang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must not be taking: Anticoagulants, Hormonal contraceptives, others

Disqualifiers: Thromboembolic disease, Pregnancy, Renal impairment, 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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tranexamic acid, applied directly during surgery, can reduce the risk of hematomas (blood clots) after breast surgery. It focuses on patients undergoing either breast reduction or gender-affirming mastectomy. Suitable participants are those having these surgeries, provided they do not have certain health conditions like blood clotting disorders or allergies to the treatment. The trial compares two groups: one receives the tranexamic acid treatment, and the other receives standard care without it. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, such as systemic anticoagulants and combined hormonal contraceptives, before participating.

What is the safety track record for tranexamic acid injection?

Research has shown that topical tranexamic acid (TXA) is generally safe for use. Studies have found that TXA can significantly reduce the risk of hematomas, or blood pooling under the skin, after breast surgery.

One study found that TXA lowered the risk of hematomas by 61% and also reduced the chance of fluid build-up, known as seromas. This indicates that TXA not only helps prevent these issues but is also safe.

Although some studies are small and varied, they consistently show that TXA does not cause major side effects. This makes it a promising option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using topical tranexamic acid (TXA) in breast surgery because it offers a new approach to reducing hematoma risk. Unlike traditional methods that might rely on systemic administration or no additional intervention, this treatment involves applying TXA directly to the surgical site through irrigation. This direct application could minimize bleeding more effectively and decrease the likelihood of complications without affecting the whole body, potentially leading to faster recovery and fewer side effects.

What evidence suggests that topical tranexamic acid is effective for reducing hematoma risk in breast surgery?

Research has shown that tranexamic acid (TXA) can reduce the risk of bruising caused by bleeding under the skin during breast surgery. In this trial, participants will be assigned to one of two groups: one group will receive irrigation containing TXA, while the other group will receive no additional irrigation as part of usual care. One study found that TXA lowered the chance of bruising by 52%, reducing the risk to less than half compared to not using TXA. Another study demonstrated a 61% decrease in the risk of bruising and a 31% reduction in fluid buildup. These findings suggest that TXA can significantly reduce bleeding problems in breast surgeries. Overall, TXA appears to be a promising option for lowering the risk of bruising in these procedures. ^{2 3 4 6 7}

Who Is on the Research Team?

Edwin Wilkins, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for patients undergoing bilateral breast reduction or gender-affirming mastectomy with no restrictions on the type of skin incision or surgery. It's not for those with color vision issues, kidney problems, sensitivity to tranexamic acid, using anticoagulants or certain contraceptives, a history of brain hemorrhage, pregnant women, or anyone at risk of blood clots.

Inclusion Criteria

I am having or had a gender-affirming mastectomy with any type of skin incision.

I am having surgery to reduce both breasts or for gender-affirming mastectomy.

I am having a breast reduction and any surgical method is okay.

Exclusion Criteria

I am currently taking blood thinners.

You are allergic to tranexamic acid.

My kidney function is impaired or my creatinine level is above 1.5 mg/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical tranexamic acid during breast surgery to evaluate its effect on preventing hematomas

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on thromboembolic events and other complications

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid injection

Trial Overview The study tests if applying tranexamic acid directly onto the surgical area can prevent bleeding complications like hematomas after breast surgery. Patients are randomly chosen to either receive this treatment or no additional intervention during their procedure.

How Is the Trial Designed?

Group I: No additional irrigation usual care Experimental Treatment 1 Intervention

Group II: Irrigation that contains tranexamic acid (TXA) Experimental Treatment 1 Intervention

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

Approved in European Union as Cyklokapron for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery
• Hereditary angioedema

Approved in United States as Lysteda for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery

Approved in Canada as Tranexamic Acid Injection for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery

Approved in Japan as Tranexamic Acid Injection for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study of 131 patients undergoing dermatologic surgery, subcutaneous injection of tranexamic acid (TXA) significantly reduced bleeding compared to a placebo, with a notable bloodstain to surgical wound size ratio of 1.77 in the TXA group versus 2.49 in the placebo group.

TXA was particularly effective in patients on anticoagulants, showing improved hemostasis and safety, making it a valuable option for reducing surgical bleeding in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Zilinsky, I., Barazani, TB., Visentin, D., et al.[2019]

In a study involving 202 patients undergoing mastectomy, applying tranexamic acid (TXA) topically to the surgical wound significantly reduced postoperative bleeding, as indicated by lower drain production in the first 24 hours (110 ml vs. 144 ml for placebo).

The use of TXA also showed a trend towards fewer early hematomas compared to the placebo group (1 vs. 7), suggesting a potential benefit in reducing complications, while no significant differences in overall postoperative complications were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. Ausen, K., Hagen, AI., Østbyhaug, HS., et al.[2021]

In a study involving 125 patients undergoing total knee arthroplasty, the use of topical tranexamic acid (TXA) combined with povidone-iodine significantly improved postoperative hemoglobin levels and reduced blood loss compared to a control group that only received povidone-iodine.

The application of TXA did not lead to any significant complications, indicating that it is a safe and effective method to minimize bleeding during and after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding reduction after topical application of tranexamic acid together with Betadine solution in total knee arthroplasty. A randomised controlled study. Carvalho, LH., Frois Temponi, E., Machado Soares, LF., et al.[2018]

In a study involving 98 patients undergoing breast reduction surgery, the use of topical tranexamic acid (TXA) did not significantly reduce the incidence of postoperative hematomas, with a hematoma rate of 1.5% in both TXA and placebo groups.

No adverse effects or complications related to TXA were observed, indicating that while TXA is safe, it may not be effective in preventing hematomas in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Tranexamic Acid Does Not Reduce The Incidence Of Hematoma In Reduction Mammoplasty: A Double-Blinded, Randomized Placebo-Controlled Trial. Yao, A., Wang, F., Benacquista, T., et al.[2023]

In a randomized double-blind trial involving 160 women with breast cancer, the use of tranexamic acid significantly reduced postoperative drainage volume (283 ml vs. 432 ml) compared to placebo, indicating its efficacy in managing fluid accumulation after surgery.

Tranexamic acid also decreased the frequency of postoperative seroma formation (27% vs. 37%), suggesting it may help reduce wound complications following breast cancer surgery, with no increase in infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative and postoperative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. Oertli, D., Laffer, U., Haberthuer, F., et al.[2019]

In a study of 415 patients undergoing reduction mammaplasty, the use of topical tranexamic acid (TXA) significantly reduced the incidence of postoperative hematomas requiring evacuation from 5.8% in the control group to just 0.6% in the TXA group (p = 0.008).

No adverse events related to the use of topical TXA were reported, suggesting it is a safe intervention that could potentially prevent the need for reoperations due to bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid reduces postoperative hematomas in reduction mammaplasties. Sipos, K., Kämäräinen, S., Kauhanen, S.[2023]

Intraoperative injection of tranexamic acid (TXA) during total knee arthroplasty (TKA) significantly reduced postoperative blood loss and the need for blood transfusions, as shown in a study of 100 patients.

The TXA group experienced lower drainage volumes and milder ecchymosis compared to the control group, indicating that TXA is both effective and safe for minimizing hemorrhage during TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety evaluation of intra-articular injection of tranexamic acid in total knee arthroplasty operation with temporarily drainage close. Wang, G., Wang, D., Wang, B., et al.[2020]

Locally injected tranexamic acid (TXA) at a concentration of 1 mg/mL significantly improved the clarity of the surgical field during subcutaneous tumor excisions, especially in patients on antithrombotic drugs, leading to better surgical outcomes.

The use of TXA also reduced the incidence of minor postoperative complications, such as hematomas and infections, and shortened hospital stays by allowing for quicker drain removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of local infiltration of tranexamic acid in subcutaneous surgery: A protocol from a single medical center. Chang, YJ., Lin, YH., Wang, PL., et al.[2023]

In a study of 49 patients undergoing simultaneous bilateral total knee arthroplasty, the use of topical tranexamic acid (TA) significantly reduced the rate of blood transfusions from 67% to 4% and decreased net hemoglobin loss compared to those who did not receive TA.

Topical TA administration also led to a shorter postoperative hospital stay by an average of 1.1 days, with no increase in the risk of thromboembolic events, indicating its safety and efficacy in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid reduces transfusion rates in simultaneous bilateral total knee arthroplasty: a retrospective case series. Kim, C., Park, SS., Dhotar, HS., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1526820925000205

Tranexamic Acid in Breast Surgery – A Systematic Review ... Tranexamic acid (TXA) is suggested to decrease the risk of postoperative hematoma, but the evidence is based on small and heterogeneous studies.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36995174/

The Effects of Tranexamic Acid in Breast Surgery TXA administration reduced hematoma formation in breast surgery (risk ratio, 0.48; 95% CI 0.32 to 0.73), with no effect on drain output (mean ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02615366

Tranexamic Acid for Bleeding in Breast Surgery The aim of this study is to determine if TXA is superior to placebo in reducing the bleeding complications in breast surgeries.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12312098/

Topical tranexamic acid in mastectomies on haematoma ... The findings of the present study show that topical TXA significantly reduced haematoma formation and drain output in patients who had undergone ...

5. nesps.org nesps.org/meeting/program/2025/77.cgi

Tranexamic Acid in Breast Surgery: 10 Years of ... TXA use was associated with a 61% reduction in hematoma risk (OR 0.39; 95% CI, 0.25-0.75) and a 31% reduction in seroma formation (OR 0.69; 95% CI, 0.23-0.81).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05441592

A Randomized Control Trial Assessing the Effect of Topical ... This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04918576?term=AREA%5BConditionSearch%5D(Postoperative%20hematoma)&rank=6

Study Details | Topical Tranexamic Acid for Bilateral Breast ... The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease ...