Trial Outcomes & Findings for Use of Tranexamic Acid in Reduction Mammoplasty (NCT NCT04947514)
NCT ID: NCT04947514
Last Updated: 2023-04-10
Results Overview
The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2023-04-10
Participant Flow
Patients undergoing bilateral reduction mammoplasty were enrolled in this study. One breast was randomized to receive the treatment, the other received a placebo; therefore, there were 98 patients enrolled and 196 "treated" breasts.
Unit of analysis: Breasts
Participant milestones
| Measure |
Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline)
Each patient undergoing routine bilateral breast reduction was randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast received topical saline.
Treatment: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
OR
Placebo (topical saline): The untreated breast will receive topical saline.
|
|---|---|
|
Overall Study
STARTED
|
98 196
|
|
Overall Study
COMPLETED
|
98 196
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Tranexamic Acid in Reduction Mammoplasty
Baseline characteristics by cohort
| Measure |
Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline)
n=196 Breasts
Each patient undergoing routine bilateral breast reduction was randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast received topical saline.
Treatment: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
OR
Placebo (topical saline): The untreated breast will receive topical saline.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
34.14 years
STANDARD_DEVIATION 12.87 • n=99 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
57 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: One of the two breasts was randomized to receive the study drug, the other breast was randomized to receive saline. As all participants had a bilateral operation performed, there were 196 analyzed units for 98 participants.
The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.
Outcome measures
| Measure |
Treatment Side (Right or Left)
n=98 Breast
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Tranexamic acid: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
|
Placebo Side (Right or Left)
n=98 Breast
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Placebo (topical saline): The untreated breast will receive topical saline.
|
|---|---|---|
|
Number of Breasts With Development of Hematoma
|
2 breasts
|
1 breasts
|
SECONDARY outcome
Timeframe: Up to 30 daysThe number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level
Outcome measures
| Measure |
Treatment Side (Right or Left)
n=98 Participants
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Tranexamic acid: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
|
Placebo Side (Right or Left)
n=98 Participants
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Placebo (topical saline): The untreated breast will receive topical saline.
|
|---|---|---|
|
Number of Participants Requiring a Blood Transfusion
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 daysIncidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan)
Outcome measures
| Measure |
Treatment Side (Right or Left)
n=98 Participants
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Tranexamic acid: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
|
Placebo Side (Right or Left)
n=98 Participants
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Placebo (topical saline): The untreated breast will receive topical saline.
|
|---|---|---|
|
Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Side (Right or Left)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Side (Right or Left)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place