Trial Outcomes & Findings for A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery (NCT NCT05441592)
NCT ID: NCT05441592
Last Updated: 2025-11-26
Results Overview
Results reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
Up to approximately 4 weeks after surgery
Results posted on
2025-11-26
Participant Flow
Participant milestones
| Measure |
Irrigation that contains tranexamic acid (TXA)
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
52
|
|
Overall Study
COMPLETED
|
54
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Irrigation that contains tranexamic acid (TXA)
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
Baseline Characteristics
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Baseline characteristics by cohort
| Measure |
Irrigation That Contains Tranexamic Acid (TXA)
n=55 Participants
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No Additional Irrigation Usual Care
n=52 Participants
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex/Gender, Customized
Female
|
7 Participants
n=9 Participants
|
16 Participants
n=32 Participants
|
23 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
24 years
n=9 Participants
|
28 years
n=32 Participants
|
26 years
n=18 Participants
|
|
Sex/Gender, Customized
Transgender Female
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Transgender Male
|
34 Participants
n=9 Participants
|
25 Participants
n=32 Participants
|
59 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
14 Participants
n=9 Participants
|
11 Participants
n=32 Participants
|
25 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
7 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=9 Participants
|
49 Participants
n=32 Participants
|
98 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
5 Participants
n=32 Participants
|
9 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=9 Participants
|
41 Participants
n=32 Participants
|
84 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
5 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
5 Participants
n=32 Participants
|
8 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=9 Participants
|
52 Participants
n=32 Participants
|
107 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 4 weeks after surgeryResults reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.
Outcome measures
| Measure |
Irrigation that contains tranexamic acid (TXA)
n=54 Participants
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
n=47 Participants
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Hematomas
|
0 hematomas
|
1 hematomas
|
SECONDARY outcome
Timeframe: Up to approximately 4 weeks after surgeryResults reflect the number of participants who experienced any major thromboembolic event during the trial. Major thromboembolic events included, but were not limited to, deep vein thrombosis, pulmonary embolism, and stroke.
Outcome measures
| Measure |
Irrigation that contains tranexamic acid (TXA)
n=54 Participants
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
n=47 Participants
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 4 weeks after surgeryResults reflect the number of participants who experienced any major complication other than a hematoma. Major complications included, but were not limited to, infection, seroma, hypersensitivity reaction to TXA, and renal impairment.
Outcome measures
| Measure |
Irrigation that contains tranexamic acid (TXA)
n=54 Participants
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
n=47 Participants
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Participants Who Experienced Major Complications Other Than Hematoma
|
0 Participants
|
2 Participants
|
Adverse Events
Irrigation that contains tranexamic acid (TXA)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
No additional irrigation usual care
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irrigation that contains tranexamic acid (TXA)
n=55 participants at risk
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
n=52 participants at risk
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hematoma Requiring Reoperation
|
0.00%
0/55 • 4 weeks
|
1.9%
1/52 • 4 weeks
|
Other adverse events
| Measure |
Irrigation that contains tranexamic acid (TXA)
n=55 participants at risk
Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
|
No additional irrigation usual care
n=52 participants at risk
No additional irrigation: There will be no additional irrigation after the standard surgical procedure.
|
|---|---|---|
|
Infections and infestations
Surgical site infection
|
0.00%
0/55 • 4 weeks
|
3.8%
2/52 • 4 weeks
|
|
Injury, poisoning and procedural complications
Delayed wound healing
|
7.3%
4/55 • 4 weeks
|
9.6%
5/52 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/Dermatitis
|
5.5%
3/55 • 4 weeks
|
1.9%
1/52 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place