Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irrigation that contains tranexamic acid (TXA) | Experimental |
| |
| No additional irrigation usual care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 4 weeks after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edwin Wilkins, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No additional irrigation usual care | No additional irrigation: There will be no additional irrigation after the standard surgical procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | hematomas | Up to approximately 4 weeks after surgery |
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma Requiring Reoperation | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical site infection | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwin Wilkins | University of Michigan | 734-936-6680 | ewilkins@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2022 | Oct 15, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No additional irrigation | Other | There will be no additional irrigation after the standard surgical procedure. |
|
| 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. | Up to approximately 4 weeks after surgery |
| No Additional Irrigation Usual Care |
No additional irrigation: There will be no additional irrigation after the standard surgical procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to approximately 4 weeks after surgery |
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to approximately 4 weeks after surgery |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 6 |
| 55 |
| EG001 | No additional irrigation usual care | No additional irrigation: There will be no additional irrigation after the standard surgical procedure. | 0 | 52 | 1 | 52 | 6 | 52 |
| Delayed wound healing | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rash/Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided