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Impact of Topical Tranexamic Acid in Breast Reconstruction
Phase 4 trial testing Tranexamic Acid in Breast Cancer in 23 participants. Terminated before completion.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 23 |
| Start date | 20 April 2023 |
| Primary completion | 30 November 2024 |
| Estimated completion | 30 November 2024 |
| Sites | 1 location across United States |
University of California, San Francisco
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0 |
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0 |
Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0 |
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0 |
Ecchymosis will be measured separately for the right and left breast pocket at each post operative visit and documented. The observer will be blinded to the laterality of TXA. Both participant and provider will be asked to rank which side, the right or left side, has worse bruising. The frequency of ecchymosis for the right and left side will be reported descriptively.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0 |
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0 |
Total drain output over the life of the drain from drain placement in the operating room to discharge on post-operation day 1. Drains will be removed per standard practice at our institution which is when they have produced \< 30 cubic centimeters (cc) per day for at least 3 days.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 95 | 35 – 293 |
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 90 | 25 – 291 |
The median time of total drain duration from drain placement in the operating room to removal of the drain will be reported descriptively for the saline only and TXA treated breast.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 14 | 8 – 32 |
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 14 | 8 – 32 |
The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 1 |
The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 0.26 |
Time frame: Up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tranexamic Acid (TXA) (Rig… | Saline (Left Side Breast P… |
|---|---|---|---|
| Breast Infection | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT05807074 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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