Hematoma Postoperative
Conditions
Keywords
Breast reduction, Gender-affirming mastectomy, Tranexamic Acid
Brief summary
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
Interventions
DRUGTranexamic 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.
OTHERNo additional irrigation
There will be no additional irrigation after the standard surgical procedure.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy * For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable. * For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
Exclusion criteria
* Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion * Current use of systemic anticoagulation * Hypersensitivity to tranexamic acid * Concomitant use of combined hormonal contraceptives * Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid * History of acquired defective color vision * History of subarachnoid hemorrhage * Pregnancy * History of renal impairment or serum Creatinine \>1.5 milligrams per deciliter (mg/dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematomas | Up to approximately 4 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug | Up to approximately 4 weeks after surgery | Results 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. |
| Participants Who Experienced Major Complications Other Than Hematoma | Up to approximately 4 weeks after surgery | Results 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| No Additional Irrigation Usual Care No additional irrigation: There will be no additional irrigation after the standard surgical procedure. | 52 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 |
Baseline characteristics
| Characteristic | No Additional Irrigation Usual Care | Total | Irrigation That Contains Tranexamic Acid (TXA) |
|---|---|---|---|
| Age, Continuous | 28 years | 26 years | 24 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 98 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 41 Participants | 84 Participants | 43 Participants |
| Region of Enrollment United States | 52 Participants | 107 Participants | 55 Participants |
| Sex/Gender, Customized Female | 16 Participants | 23 Participants | 7 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Non-Binary | 11 Participants | 25 Participants | 14 Participants |
| Sex/Gender, Customized Transgender Female | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender Male | 25 Participants | 59 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 52 |
| other Total, other adverse events | 6 / 55 | 6 / 52 |
| serious Total, serious adverse events | 0 / 55 | 1 / 52 |
Outcome results
Primary
Hematomas
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.
Time frame: Up to approximately 4 weeks after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Irrigation that contains tranexamic acid (TXA) | Hematomas | 0 hematomas |
| No additional irrigation usual care | Hematomas | 1 hematomas |
p-value: 0.486Fisher Exact
Secondary
Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug
Results 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.
Time frame: Up to approximately 4 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Irrigation that contains tranexamic acid (TXA) | Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug | 0 Participants |
| No additional irrigation usual care | Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug | 0 Participants |
Secondary
Participants Who Experienced Major Complications Other Than Hematoma
Results 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.
Time frame: Up to approximately 4 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Irrigation that contains tranexamic acid (TXA) | Participants Who Experienced Major Complications Other Than Hematoma | 0 Participants |
| No additional irrigation usual care | Participants Who Experienced Major Complications Other Than Hematoma | 2 Participants |
p-value: 0.234Fisher Exact