Tranexamic Acid for Breast Reconstruction

Overseen By Rachel Park, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Virginia

Disqualifiers: Allergy to TXA, Anemia, Pregnancy, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 0-1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tranexamic acid (TXA), a medication that reduces bleeding, affects women undergoing breast reconstruction surgery with free flap techniques. Researchers aim to determine if TXA can reduce the need for blood transfusions and improve surgical outcomes without increasing complications. Participants will be divided into two groups: one receiving TXA and the other a placebo (inactive treatment). The trial seeks women undergoing breast reconstruction surgery at UVA Medical Center. As a Phase 4 trial, TXA is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for tranexamic acid?

Research has shown that tranexamic acid (TXA) is generally safe for use in breast surgery. Studies have found that TXA can reduce the incidence of hematomas, or blood collections outside blood vessels, from 5.4% to 2.5%. This reduction means fewer patients experienced issues with blood pooling when using TXA. Additionally, TXA helps decrease blood loss during surgery, potentially reducing the need for blood transfusions.

Evidence also indicates that TXA can speed up recovery by shortening the time until surgical drains are removed. Importantly, past studies did not find an increased risk of complications such as microanastomosis failure, where small blood vessel connections fail.

While TXA is approved for other surgeries, its use in breast reconstruction is still under study for specific safety data. However, current research suggests it is safe and effective for reducing bleeding-related issues. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tranexamic acid (TXA) is unique because it helps reduce blood loss during breast reconstruction surgery by preventing blood clots from breaking down too quickly. Unlike other treatments for this condition, which often involve managing bleeding with transfusions or other blood products after it occurs, TXA acts proactively to minimize bleeding from the start. Researchers are excited about TXA because it could lead to fewer complications, shorter recovery times, and less need for blood transfusions, making the surgical process safer and more efficient for patients.

What evidence suggests that tranexamic acid might be an effective treatment for breast reconstruction?

Research has shown that tranexamic acid (TXA), which participants in this trial may receive, helps reduce blood loss during surgery. Studies have found that TXA can significantly lower the risk of hematomas—solid swellings of clotted blood—and decrease the need for surgical drains after breast surgery. In mastectomies, TXA reduced hematoma formation and shortened the time patients needed drains. It stabilizes the blood clotting process, helping to control bleeding. While clear data on its use in free flap breast reconstruction is not yet available, evidence from other breast surgeries suggests TXA could help reduce complications from blood loss. ^{1 2 6 7 8}

Who Is on the Research Team?

John Stranix, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for patients undergoing breast reconstruction with free flap surgery after mastectomy due to breast cancer. Participants must not have a history of clotting or bleeding disorders, and should not be currently receiving anticoagulant therapy. They also need to be fit for the surgical procedure as per standard medical evaluation.

Inclusion Criteria

I am a woman over 18 planning to have breast reconstruction with abdomen tissue at UVA Medical Center.

Exclusion Criteria

Subjects who are pregnant

Allergy to TXA

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast free flap reconstruction surgery with or without TXA administration

0-1 week

1 visit (in-person)

Post-operative Care

Participants receive post-operative care following the ERAS protocol, including monitoring of hemoglobin levels and transfusion rates

0-4 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for surgical complications and overall recovery, including thromboembolic events and flap failure

30 days

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid

Trial Overview The study is testing whether Tranexamic acid (TXA), a drug that helps reduce bleeding, can benefit patients during breast reconstruction surgery by comparing it with a placebo. The goal is to see if TXA reduces blood loss, the need for transfusions, and improves surgical outcomes without increasing risks like clot formation.

How Is the Trial Designed?

Group I: TXA group Experimental Treatment 1 Intervention

Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA

Group II: Placebo group Placebo Group 1 Intervention

Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline

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

Approved in United States as Lysteda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma

Approved in European Union as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Approved in Japan as Nicolda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Fondaparinux sodium is a selective factor Xa inhibitor used for preventing blood clots (thromboprophylaxis) in various patient groups, including those undergoing cesarean delivery.

Recent literature suggests careful consideration of the timing and safety of neuraxial anesthesia in patients who have recently used fondaparinux, highlighting the need for updated guidelines in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia for cesarean delivery in a patient receiving fondaparinux. Rentz, JB., Hart, SR., Russo, M.[2021]

In a study of 88 patients undergoing total knee arthroplasty, the use of tranexamic acid significantly reduced postoperative blood loss and increased postoperative hemoglobin levels compared to the control group.

The use of tranexamic acid did not increase the risk of deep venous thrombosis (DVT), indicating it is a safe option for managing blood loss during TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of tranexamic acid in total knee arthroplasty]. Chen, X., Xie, S., Wang, K.[2018]

A new class of selective FXIIIa inhibitors, specifically compound 8, effectively reduces fibrin cross-linking and inhibits clot formation in human plasma, demonstrating a 50% reduction at a concentration of 160 µM.

The effectiveness of compound 8 in promoting fibrinolysis is dose-dependent, meaning higher concentrations lead to faster breakdown of clots when treated with tissue plasminogen activator.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3-Substituted imidazo[1,2-d][1,2,4]-thiadiazoles: a novel class of factor XIIIa inhibitors. Leung-Toung, R., Tam, TF., Wodzinska, JM., et al.[2014]

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]

Xai-K, a chemically modified non-enzymatic form of Factor Xa, demonstrated significant thrombolytic activity in mice without activating systemic fibrinolysis markers, indicating a safer profile compared to traditional thrombolytic agents like recombinant tPA.

In murine models, Xai-K enhanced clot dissolution by approximately 7-fold and allowed for a more than 30-fold reduction in the required dose of the tPA variant Tenecteplase, suggesting it could improve the efficacy and safety of thrombolytic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thrombolysis by chemically modified coagulation factor Xa. Pryzdial, EL., Meixner, SC., Talbot, K., et al.[2023]

Fondaparinux sodium is a novel antithrombotic agent that specifically inhibits factor Xa and requires binding to antithrombin, making it distinct from traditional heparin and low-molecular-weight heparins.

It has been approved for preventing venous thrombosis after orthopedic surgery with a fixed daily dose of 2.5 mg, eliminating the need for monitoring, which enhances its practicality for patient use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-acting synthetic pentasaccharides as antithrombotic agents. Walenga, JM., Jeske, WP., Fareed, J.[2019]

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]

Fondaparinux sodium is a highly effective and safe anticoagulant for preventing and treating venous thromboembolic events, with established efficacy in various clinical settings since its approval in 2002.

Recent studies have expanded the use of fondaparinux to additional conditions, such as acute coronary syndromes and in patients intolerant to other anticoagulants, leading to updates in clinical guidelines that recommend its use in these scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fondaparinux Sodium: Recent Advances in the Management of Thrombosis. Bauersachs, RM.[2023]

In a double-blind trial involving patients with hemophilia and Christmas disease, tranexamic acid (1 g three times a day for five days) significantly reduced blood loss and the need for blood transfusions after dental extractions.

The study found no side effects or toxic effects on the liver, kidney, or heart, indicating that tranexamic acid is a safe option for managing bleeding in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid in control of haemorrhage after dental extraction in haemophilia and Christmas disease. Forbes, CD., Barr, RD., Reid, G., et al.[2019]

In a study of 60 patients undergoing bilateral total knee arthroplasty, intravenous tranexamic acid (TXA) significantly reduced total blood loss and the need for blood transfusions compared to the control group, indicating its efficacy in managing perioperative blood loss.

The use of TXA did not increase the risk of deep vein thrombosis or other thromboembolic events, suggesting it is a safe option for patients undergoing knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A PROSPECTIVE RANDOMIZED SELF-CONTROLLED STUDY ON EFFECT OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS IN TOTAL KNEE ARTHROPLASTY]. Huang, Z., Zhang, W., Li, W., et al.[2018]

Citations

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

Tranexamic Acid in Breast Surgery – A Systematic Review ... The results demonstrate that both forms of TXA significantly reduce hematoma formation and reduce drain output and time until drain removal in breast surgery.

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

Topical tranexamic acid in mastectomies on haematoma ... Reports suggest tranexamic acid (TXA) reduces haematoma formation after breast surgery. This study investigated the effects of postoperative ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525001949

Review The current state of tranexamic acid in mastectomy ... TXA administration was found to significantly reduce postoperative hematoma formation, drain duration, and 24-hour drain output, without impacting seroma or SSI ...

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

Tranexamic Acid in Breast Surgery: 10 Years of ... Conclusions: This decade-spanning meta-analysis of prospective studies provides robust evidence that TXA significantly reduces hematoma and seroma rates in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05807074

Impact of Topical Tranexamic Acid in Breast Reconstruction This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12023121/

189.: The Current State of Tranexamic Acid in Breast ... Results from 1682 patients (TXA: 714, control: 968) identified 2.5% (18) developed hematomas in the TXA group, relative to 5.4% (53) in the control group, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11298145/

Topical Tranexamic Acid (TXA) Decreases Time to Drain ... The primary outcome was days to drain removal. Secondary outcomes include daily inpatient drain output, postoperative hemoglobin levels, blood transfusions, and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02615366

Tranexamic Acid for Bleeding in Breast Surgery Perioperative TXA use is superior to placebo in reducing bleeding complications (ie. hematoma, seroma, and excessive blood loss) in the surgical or donor site.