Tranexamic Acid for Breast Reconstruction

Overseen By Serena Bhaskerrao

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Anticoagulants, Chlorpromazine, Prothrombotics

Disqualifiers: Thromboembolic disease, Allergic to TXA, Male, 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: Intra-operative

23 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Merisa Piper, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for women over 18 who are having both breasts removed and reconstructed due to breast cancer or high risk of it. They must understand and sign a consent form, be at least 4 weeks post-chemo or radiation, with no allergies to TXA, no current use of certain drugs like chlorpromazine or prothrombotic products, not on anticoagulants, and have no history of blood clots.

Inclusion Criteria

I am scheduled for a bilateral mastectomy with reconstruction.

Ability to understand a written informed consent document, and the willingness to sign it

It has been over 4 weeks since I finished my chemotherapy or radiation therapy.

Exclusion Criteria

Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study

I am currently taking blood thinners.

I am currently taking chlorpromazine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-operative treatment with topical TXA to one breast pocket, serving as their own control with saline applied to the other breast pocket

Intra-operative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including seroma and hematoma formation, drain output, and infection rates

Up to 1 year

Regularly scheduled visits up to one year post-operatively

Treatment Details

Interventions

• Tranexamic Acid

Trial Overview The study tests the effectiveness of applying Tranexamic Acid (TXA) topically during bilateral mastectomy followed by reconstruction. It aims to see if TXA can reduce bleeding and fluid collection after surgery compared to using saline solution.

Participant Groups

Group I: TXA, Saline Experimental Treatment 2 Interventions

Each participant will have one breast exposed to TXA in the breast pocket 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 Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+