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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-02817 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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Slow Accrual
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Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients.
Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.
PRIMARY OUTCOMES:
I. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.
II. To evaluate the impact of TXA on seroma rates compared to control.
SECONDARY OUTCOMES:
I. To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.
II. To evaluate the impact of TXA on total drain output in the first post operative day.
III. To evaluate the impact of TXA on total drain duration.
OUTLINE:
Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | Each participant will have one breast pocket exposed to TXA and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Applied intraoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Breast Pockets That Develop a Hematoma | Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported. | Up to 1 month |
| Number of Breast Pockets That Develop a Seroma | Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Breast Pockets That Developed Ecchymosis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merisa Piper, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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All participants received the same intervention to the same breast pocket during bilateral mastectomy surgery before the study was closed prematurely to enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Number of Breast Pockets That Develop a Hematoma | Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported. | A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets | Posted | Number | breast pocket | Up to 1 month | breast pockets | breast pockets |
|
Up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid (TXA) (Right Side 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment | 3 participants (4 of 6 breasts) had infections in the TXA-treated breast, and 3 participants (4 of 6 breasts) had infections in the saline-treated breast |
Study closed to enrollment earlier than expected due to slow accrual. As a result, all participants received the same intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Merisa Piper, MD | University of California, San Francisco | (415) 353-4320 | Merisa.Piper@ucsf.edu |
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| 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 | Jan 26, 2024 | Jul 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Saline | Other | Applied intraoperatively |
|
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| Up to 1 year |
| Median Total Drain Output | 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. | Approximately 1 month |
| Median Total Drain Duration | 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. | Approximately 1 month |
| Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy | The number of participants requiring an additional operation related to the bilateral mastectomy will be reported. | Up to 1 year |
| Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy | The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported. | Up to 1 year |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
| breast pockets |
|
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| Primary | Number of Breast Pockets That Develop a Seroma | Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported. | A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets | Posted | Number | breast pocket | Up to 3 months | breast pockets | breast pockets |
|
|
|
| Secondary | Number of Breast Pockets That Developed Ecchymosis | 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. | A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets | Posted | Number | breast pockets | Up to 1 year | breast pockets | breast pockets |
|
|
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| Secondary | Median Total Drain Output | 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. | A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets | Posted | Median | Full Range | cubic centimeter (cc) per day | Approximately 1 month | breast pockets | breast pockets |
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| Secondary | Median Total Drain Duration | 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. | A total of 23 breast pockets received TXA, and a total of 23 breast pockets received saline for a total of 46 breast pockets | Posted | Median | Full Range | days | Approximately 1 month | breast pocket | breast pocket |
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| Secondary | Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy | The number of participants requiring an additional operation related to the bilateral mastectomy will be reported. | 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 | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy | The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported. | 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 | Posted | Number | proportion of participants | Up to 1 year |
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| 0 |
| 23 |
| 0 |
| 23 |
| 3 |
| 23 |
| EG001 | Saline (Left Side 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. | 0 | 23 | 0 | 23 | 3 | 23 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Saline Breast Pocket |
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| Saline Breast Pocket |
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| Saline Breast Pocket |
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| Saline Breast Pocket |
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