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NCT05807074 · ClinicalTrials.gov registry record · Phase 4
Impact of Topical Tranexamic Acid in Breast Reconstruction
A Phase 4 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT05807074: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.
NCT05807074 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05807074, a Phase 4 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
Interventions
- OTHER Saline
- DRUG Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-04-20 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 4 |
Why NCT05807074 stopped before completion
NCT05807074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT05807074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05807074 about?
NCT05807074 is a clinical study titled "Impact of Topical Tranexamic Acid in Breast Reconstruction". 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-operati...
What is the current status of trial NCT05807074?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2023-04-20. Estimated completion is 2024-11-30.
What interventions are being tested in trial NCT05807074?
The interventions under investigation include: Saline (OTHER), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT05807074?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05807074's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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