Trial Outcomes & Findings for Impact of Topical Tranexamic Acid in Breast Reconstruction (NCT NCT05807074)
NCT ID: NCT05807074
Last Updated: 2025-09-29
Results Overview
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
TERMINATED
PHASE4
23 participants
Up to 1 month
2025-09-29
Participant Flow
All participants received the same intervention to the same breast pocket during bilateral mastectomy surgery before the study was closed prematurely to enrollment.
Unit of analysis: breast pocket
Participant milestones
| Measure |
All Participants
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Overall Study
STARTED
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23 46
|
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Overall Study
Received TXA (Right Side)
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23 23
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Overall Study
Received Saline (Left Side)
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23 23
|
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Overall Study
COMPLETED
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23 46
|
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Topical Tranexamic Acid in Breast Reconstruction
Baseline characteristics by cohort
| Measure |
All Participants
n=23 Participants
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Age, Customized
20-29 years old
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4 Participants
n=5 Participants
|
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Age, Customized
30-39 years old
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4 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
10 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
Outcome measures
| Measure |
All Participants
n=46 breast pockets
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Number of Breast Pockets That Develop a Hematoma
TXA Breast Pocket
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0 breast pocket
|
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Number of Breast Pockets That Develop a Hematoma
Saline Breast Pocket
|
0 breast pocket
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets
Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.
Outcome measures
| Measure |
All Participants
n=46 breast pockets
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Number of Breast Pockets That Develop a Seroma
TXA Breast Pocket
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0 breast pocket
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Number of Breast Pockets That Develop a Seroma
Saline Breast Pocket
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0 breast pocket
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets
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.
Outcome measures
| Measure |
All Participants
n=46 breast pockets
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Number of Breast Pockets That Developed Ecchymosis
TXA Breast Pocket
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0 breast pockets
|
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Number of Breast Pockets That Developed Ecchymosis
Saline Breast Pocket
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0 breast pockets
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SECONDARY outcome
Timeframe: Approximately 1 monthPopulation: A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets
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.
Outcome measures
| Measure |
All Participants
n=46 breast pockets
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Median Total Drain Output
TXA Breast Pocket
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95 cubic centimeter (cc) per day
Interval 35.0 to 293.0
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Median Total Drain Output
Saline Breast Pocket
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90 cubic centimeter (cc) per day
Interval 25.0 to 291.0
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SECONDARY outcome
Timeframe: Approximately 1 monthPopulation: A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets
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.
Outcome measures
| Measure |
All Participants
n=46 breast pocket
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Median Total Drain Duration
TXA Breast Pocket
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14 days
Interval 8.0 to 32.0
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Median Total Drain Duration
Saline Breast Pocket
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14 days
Interval 8.0 to 32.0
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: It was pre-specified to assess reoperation in participants without regard to treatment, therefore data for TXA and Saline are combined in this outcome measure
The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.
Outcome measures
| Measure |
All Participants
n=23 Participants
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy
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1 Participants
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: It was pre-specified to assess occurrence of post-surgical infection in participants regardless of breast pocket, therefore data for the TXA and Saline breast pockets are combined in this outcome measure
The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported.
Outcome measures
| Measure |
All Participants
n=23 Participants
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|
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Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy
|
0.26 proportion of participants
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Adverse Events
Tranexamic Acid (TXA) (Right Side Breast Pocket)
Saline (Left Side Breast Pocket)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tranexamic Acid (TXA) (Right Side Breast Pocket)
n=23 participants at risk
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
|
Saline (Left Side Breast Pocket)
n=23 participants at risk
Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.
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|---|---|---|
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Infections and infestations
Breast Infection
|
13.0%
3/23 • Number of events 4 • Up to 1 year
|
13.0%
3/23 • Number of events 4 • Up to 1 year
|
Additional Information
Dr. Merisa Piper, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place