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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Tranexamic Acid for reducing hematoma risk in breast surgery?

Research shows that tranexamic acid can reduce bleeding and complications in various surgeries, including breast cancer surgeries, where it significantly reduced postoperative drainage. However, its effectiveness in reducing hematomas specifically in breast reduction surgeries is mixed, with some studies showing no reduction in hematoma incidence. ^{1 2 3 4 5}

How is the drug tranexamic acid unique in reducing hematoma risk in breast surgery?

Tranexamic acid is unique because it can be applied topically during breast surgery to potentially reduce bleeding, offering an alternative to intravenous administration with a lower risk of systemic side effects. ^{3 6 7 8 9}

Research Team

Edwin Wilkins, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid reduces postoperative hematomas in reduction mammaplasties. [2023]

2. United States 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. [2020]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of local infiltration of tranexamic acid in subcutaneous surgery: A protocol from a single medical center. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Perioperative and postoperative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid reduces transfusion rates in simultaneous bilateral total knee arthroplasty: a retrospective case series. [2022]

9. France 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. [2018]