SurgeryPhase 4NCT04372940
Tranexamic Acid in Gender Mastectomy
A Phase 4 study testing Tranexamic Acid Irrigation and Saline Irrigation in people with Surgery, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this study is to examine the use of tranexamic acid (TXA) in gender mastectomy surgery, specifically looking at volume loss (blood and transudate) postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Tranexamic Acid Irrigation and Saline Irrigation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2023to Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing gender mastectomy
- English speaking
Who cannot join
- History of thrombotic event (ie deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
- genetic disorder that increases risk of thrombosis
- use of estrogens at time of surgery
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery
The goal of this study is to examine the use of tranexamic acid (TXA) in gender mastectomy surgery, specifically looking at volume loss (blood and transudate) postoperatively.
Read the detailed description
Anecdotal data from plastic surgeons around the country suggests that tranexamic acid has decreased patient's drain outputs, swelling, and bruising. Based on these anecdotal reports, many University of Wisconsin (UW) surgeons in Plastic and Reconstructive Surgery became interested in its use. It has a very safe profile and is inexpensive; therefore, many UW plastic surgeons have started using it topically prior to closure in many of procedures. Surgeons notice decreased drain output and bruising; and therefore decided to formally study the effects of tranexamic acid to determine whether there was a statistical difference in outcomes with the use of the drug.
For this sub-study, topical TXA will be applied to the surface of surgical sites and the primary outcome will be days to drain removal postoperatively. Secondary outcomes that would be assessed is total drain fluid output in milliliters, hematoma and seroma rates, and need for transfusion for hemoglobin < 7.0 postoperatively.
The hypothesis is that the use of TXA will result in earlier removal of drains by decreasing total drain fluid output and decreased need for transfusions, thus minimizing the associated complications/risks with drains and transfusions. The overall study is in two-parts, 1) a prospective study with retrospective controls via chart review and 2) a prospective controlled trial in bilateral procedures where participants serve as their own control with one side having tranexamic acid irrigation and the other side having saline irrigation.
This record documents a prospective controlled trial of the use of TXA in gender mastectomy, specifically.
- Conditions
- Surgery
- Being tested
- Tranexamic Acid Irrigation, Saline Irrigation
- Keywords
- gender mastectomy, top surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid IrrigationDrug
Also called TXA
Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots.
Saline IrrigationOther
Saline will serve as the control.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Side: TXA Irrigation | Experimental | 2.5% tranexamic acid will be applied directly to the wound via bulb irrigation and left in place for 5 minutes in the wound bed Receives: Drug: Tranexamic Acid Irrigation |
| Control Side: Saline Irrigation | Placebo comparator | Contralateral side will serve as a control Receives: Other: Saline Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days until drain removal
Measured: up to 30 days post-op
Secondary outcomes (8)
Total drain output in mL for total time drain is in place
Measured: up to 30 days post-op
Drain fluid output in mL/day
Measured: up to 30 days post-op
Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery
Measured: up to 30 days post-op
Amount of fluid evacuated (mL) - hematomas
Amount of fluid evacuated (mL) if hematomas require aspiration or return to the operating room in the 30 days following surgery
Measured: up to 30 days post-op
Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery
Measured: up to 30 days post-op
Amount of fluid evacuated (mL) - seromas
Amount of fluid evacuated (mL) if seromas require aspiration or return to the operating room in the 30 days following surgery
Measured: up to 30 days post-op
Number of Participants requiring transfusion for hemoglobin (Hgb) < 7.0 during postoperative admission
Measured: up to 30 days post-op
Number of units of blood transfused to maintain Hgb >7.0 in the postoperative admission
Measured: up to 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- TXA would be randomized to one side with the other acting as a control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katy Gast, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372940
- Sponsor's protocol ID
- 2019-0410-GM
- Other IDs
- A539730, SMPH/SURGERY/DENTL-PLASTC SRGY
- Status last verified
- Jan 2023
- First submitted
- 29 Apr 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT04372940
- Acronym / sponsor ID
- 2019-0410-GM
- Conditions
- Surgery
- Keywords
- gender mastectomy, top surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine the use of tranexamic acid (TXA) in gender mastectomy surgery, specifically looking at volume loss (blood and transudate) postoperatively.
Detailed description
Anecdotal data from plastic surgeons around the country suggests that tranexamic acid has decreased patient's drain outputs, swelling, and bruising. Based on these anecdotal reports, many University of Wisconsin (UW) surgeons in Plastic and Reconstructive Surgery became interested in its use. It has a very safe profile and is inexpensive; therefore, many UW plastic surgeons have started using it topically prior to closure in many of procedures. Surgeons notice decreased drain output and bruising; and therefore decided to formally study the effects of tranexamic acid to determine whether there was a statistical difference in outcomes with the use of the drug.
For this sub-study, topical TXA will be applied to the surface of surgical sites and the primary outcome will be days to drain removal postoperatively. Secondary outcomes that would be assessed is total drain fluid output in milliliters, hematoma and seroma rates, and need for transfusion for hemoglobin < 7.0 postoperatively.
The hypothesis is that the use of TXA will result in earlier removal of drains by decreasing total drain fluid output and decreased need for transfusions, thus minimizing the associated complications/risks with drains and transfusions. The overall study is in two-parts, 1) a prospective study with retrospective controls via chart review and 2) a prospective controlled trial in bilateral procedures where participants serve as their own control with one side having tranexamic acid irrigation and the other side having saline irrigation.
This record documents a prospective controlled trial of the use of TXA in gender mastectomy, specifically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- TXA would be randomized to one side with the other acting as a control
| Arm | Type | Receives |
|---|---|---|
| Intervention Side: TXA Irrigation | Experimental | Drug: Tranexamic Acid Irrigation2.5% tranexamic acid will be applied directly to the wound via bulb irrigation and left in place for 5 minutes in the wound bed |
| Control Side: Saline Irrigation | Placebo comparator | Other: Saline IrrigationContralateral side will serve as a control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing gender mastectomy
- English speaking
Key exclusion criteria (4 listed)
- History of thrombotic event (ie deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
- genetic disorder that increases risk of thrombosis
- use of estrogens at time of surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid IrrigationAlso: TXATranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots. | Drug | Intervention Side: TXA Irrigation |
| Saline IrrigationSaline will serve as the control. | Other | Control Side: Saline Irrigation |
Primary outcome
Days until drain removal
Time frame: up to 30 days post-op
8 secondary outcomes
Total drain output in mL for total time drain is in place
Time frame: up to 30 days post-op
Drain fluid output in mL/day
Time frame: up to 30 days post-op
Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery
Time frame: up to 30 days post-op
Amount of fluid evacuated (mL) - hematomas
Time frame: up to 30 days post-op
Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery
Time frame: up to 30 days post-op
Amount of fluid evacuated (mL) - seromas
Time frame: up to 30 days post-op
Number of Participants requiring transfusion for hemoglobin (Hgb) < 7.0 during postoperative admission
Time frame: up to 30 days post-op
Number of units of blood transfused to maintain Hgb >7.0 in the postoperative admission
Time frame: up to 30 days post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katy Gast, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid Irrigation and Saline Irrigation in people with Surgery, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days until drain removal (time frame: up to 30 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.