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Topical Tranexamic Acid in Breast Reconstruction
NCT05807074Phase 4
Key facts
- Status
- Terminated
- Start
- Apr 2023
- Primary completion
- Nov 2024
- Countries
- 1
- Sponsor
- University of California, San Francisco
- Modality
- Small Molecules
- Drugs
- tranexamic acid
- Conditions
- hematomaSeroma
01
Overview
Phase 4, randomised, double-blind trial of tranexamic acid in hematoma and Seroma, sponsored by University of California, San Francisco. Primary endpoints: Number of Breast Pockets That Develop a Hematoma at 1 month and Number of Breast Pockets That Develop a Seroma at 3 months. Started Apr 2023; status: terminated.
02
Design
1 arm- Study design
- RandomizedDouble-blind
All participants
Split-body design: One breast receives TXA, the other Saline.
03
Who it enrols
Adult women undergoing bilateral mastectomy with reconstruction, with no history of thromboembolic disease or current anticoagulant use.
04
Endpoints
Primary
Number of Breast Pockets That Develop a Hematoma
Number of Breast Pockets That Develop a Seroma
Secondary
Number of Breast Pockets That Developed Ecchymosis
Median Total Drain Output
Median Total Drain Duration
Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy
Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy
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