Postoperative HematomaPhase 2IVTXANCT05794321
Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
A Phase 2 study testing Intravenous TXA in people with Postoperative Hematoma and Postoperative Seroma, run by University of California, San Francisco at 1 site in United States.
Trial summary
Gender affirming surgeries (GAS) have been steadily increasing in the US, with the gender affirming mastectomy (GAM) being the most common surgery performed. Complications associated with these surgeries include hematoma and seroma. 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
- Postoperative Hematoma, Postoperative Seroma
- What is being tested?
- Intravenous TXA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to May 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years of age
- All patients who undergo gender affirming mastectomy at UCSF
- ASA I-III,
- Ability to understand a written informed consent document, and the willingness to sign it.
- Patients who fulfil WPATH guidelines/criteria for undergoing GAM. WPATH Criteria include: Persistent, well-documented gender dysphoria; capacity to make a fully informed decision and to consent for treatment; age of majority in a given country; if significant medical or mental health concerns are present, they must be reasonably well controlled; 12 continuous months of hormone therapy as appropriate to the patient's gender goals (for two referrals by a mental health professional).
Who cannot join
- <18 years old
- Unable to consent for themselves
- History of coagulopathy or bleeding disorders
- History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
- Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
- Prior history of chest surgery.
- Known hypersensitivity or allergy to TXA
- Patients with severe renal impairment .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF Department of Plastic & Reconstructive Surgery
San Francisco, California, 94131
Esther Kim, MD, Esther.kim@ucsf.edu
About this study
Gender affirming surgeries (GAS) have been steadily increasing in the US, with the gender affirming mastectomy (GAM) being the most common surgery performed. Complications associated with these surgeries include hematoma and seroma. Prior studies in orthopedics, plastic surgery, and trauma have shown significant reduction of bleeding and ecchymosis with the use of tranexamic acid (TXA). TXA is a synthetic amino acid that blocks plasminogen conversion to plasmin, to stabilize clot formation. The intravenous (IV) efficacy in reducing hematoma rates has been established in implant-based breast reconstruction, as well as in reduction mammaplasty. However, there are currently no studies investigating the use of IV TXA in patients undergoing GAM.
The investigators propose a single-center, prospective randomized control trial to evaluate the efficacy and safety of intravenous tranexamic acid in decreasing hematoma and seroma rates for top surgery patients at UCSF. Patients will be randomized into two groups, an experimental group receiving IV TXA and a control group that will not receive IV TXA.
Read more
Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Patients will be excluded if they have a history of coagulopathy, bleeding disorders or prior chest surgery. Demographic data, surgical characteristics, and postoperative outcomes will also be recorded and analyzed. The investigators hypothesize that the use of IV TXA will significantly reduce hematoma, seroma, postoperative drain output, and time to drain removal in patients undergoing GAM.
Aim 1: To evaluate the effectiveness of IV TXA in reducing intraoperative bleeding, post-operative hematoma and seroma formation, drain output, and time to drain removal in patients undergoing GAM.
Aim 2: To compare the incidence of thromboembolic events and wound complications between patients receiving IV TXA and those who do not after GAM.
Read the detailed description
This is a prospective, randomized, controlled single-surgeon trial performed at the University of California San Francisco that investigates the use of IV TXA in patients undergoing GAM. All patients who meet WPATH guidelines for GAM, undergo GAM, ASA I-III, and are >18 years old will have the opportunity to be enrolled. Patients will be randomized by a random computer generator and will be notified after randomization as to which group they are assigned.
The investigators will enroll patients into this prospective trial investigating the effect of IV TXA on postoperative bleeding, hematoma, seroma, drain output, and time to drain removal. Patients will be randomized into two groups, an experimental group receiving IV TXA and a control group that will not receive IV TXA. Patients will be excluded if they are <18 years old, have a history of prior chest surgeries, coagulopathy or bleeding disorders, and have a history of thromboembolic events including deep vein thrombosis or pulmonary embolism. Patients will also be excluded if they are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
All patients who are being scheduled to undergo bilateral mastectomy with immediate reconstruction will be recruited to participate in the study. Patients will be consented to participate in the preoperative visit.
Experimental Group: Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Postoperative care will be standard and based on established UCSF guidelines.
Control Group: Patients in the control group will not receive any TXA intraoperatively and will undergo a traditional GAM.
Tranexamic Acid is available as a sterile, single-dose. This 1g vial is readily available in the anesthesia cart in the operating room. Immediately following induction, the anesthesia team will administer 1g of TXA intravenously. After obtaining hemostasis and irrigating as per standard practice, anesthesia shall not use any other hemostatic agents.
Post-procedure, each patient will be provided with standard postoperative instructions which will include a chart to record daily drain outputs for the right and left sides. At subsequent postoperative visits, drain output will be assessed at each clinic visit to determine timing for removal. The total drain output will be measured by the patient and later logged into our chart for later analysis. Drains will be removed per standard practice at our institution which is when they have produced < 30cc/day for at least 3 days.
At each clinic visit, the investigators will assess for clinical signs of hematoma and seroma, and objectively measure aggregate drain output. Demographic data, surgical characteristics, and postoperative outcomes such as hematoma, seroma, drain output, wound complications, surgical site infections, and thromboembolic events will be recorded and analyzed. These outcomes will be evaluated in the immediate 3-month postoperative period, with a 1-year follow-up review of patient charts. The primary outcomes will include the presence of hematoma, seroma, and drain output, and time to drain removal, while the secondary outcomes will consist of thromboembolic events and wound complications.
Patients will be managed for hematoma and seroma as per standard procedure, whether with ultrasound, clinic aspiration, IR drain placement, or return to the operating room as deemed necessary by the senior surgeon.
- Conditions
- Postoperative Hematoma, Postoperative Seroma
- Being tested
- Intravenous TXA
- Keywords
- Gender Affirming Mastectomy, Tranexamic Acid, IV TXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous TXADrug
Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| IV TXA Group | Experimental | Patients in the experimental group will receive a loading dose of IV tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Postoperative care will be standard and based on established UCSF guidelines. Receives: Drug: Intravenous TXA |
| Control Group | No intervention | Patients in the control group will not receive any IV TXA intraoperatively and will undergo a traditional gender affirming mastectomy following the established standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinically Significant Hematomas
Hematoma will be defined as a collection of blood outside of blood vessels that requires intervention such as aspiration or surgical drainage. Hematomas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for hematoma formation. Patients who develop symptoms of hematoma after discharge will be instructed to seek medical attention immediately. Hematoma will be assessed immediately after mastectomy, and then at their one week postoperative clinic visit. Patients will also be instructed to report any symptoms of hematoma to their healthcare provider after discharge. Data on hematoma will be collected as a binary outcome (yes/no), as well as the size of the hematoma and type of intervention. Statistical analysis will be used to determine the factors associated with hematoma development after mastectomy.
Measured: Up to 3 months
Number of Participants with Clinically Significant Seromas
Seroma will be defined as a collection of fluid that accumulates in the surgical site after mastectomy that requires intervention such as aspiration or surgical drainage. Seromas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for seroma formation. Seroma will be assessed immediately after mastectomy, and then at their one postoperative clinic visit. Patients will also be instructed to report any symptoms of seroma to their healthcare provider after discharge. Data on seroma will be collected as a binary outcome (yes/no), as well as the type of intervention, and the duration of symptoms. Statistical analysis will be used to determine the factors associated with seroma development after mastectomy.
Measured: Up to 3 months
Total Patient Drain Output
Drain output will be defined as the amount of fluid (in milliliters) collected in surgical drains after mastectomy. The volume of fluid collected will be recorded by patients daily until the drains are removed. All patients will have surgical drains placed after mastectomy. Patients will be instructed to report any unusual drainage or bleeding to their healthcare provider. Data on drain output will be collected as a continuous variable, as well as the duration of drain placement. Statistical analysis will be used to determine the factors associated with increased drain output after mastectomy.
Measured: Up to 3 months
Time to Drain Removal
Time to drain removal will be defined as the number of days from mastectomy surgery to the day the surgical drains are removed. The timing of drain removal will be determined by the primary surgeon, based on the amount and character of fluid collected in the drain, and the presence of factors such as infection, hematoma, or seroma. However, drains will typically be removed when they have produced < 30cc/day for at least 3 days. The timing of drain removal will be recorded by nursing staff at the time of removal. Data on time to drain removal will be collected as a continuous variable, as well as the reason for early or delayed drain removal. Statistical analysis will be used to determine the factors associated with longer time to drain removal after mastectomy.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start28 Sep 2023
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HematomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to treatment arms. One treatment arm will include the use of IV TXA, the other treatment arm will receive the standard of care for treatment. Patients then remain in that same treatment arm throughout the course of the study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Kim, MD, University of California, San Francisco
- Investigators
- Esther Kim, MD, Principal investigator, UCSF Department of Plastic & Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794321
- Sponsor's protocol ID
- 23-38580
- Acronym
- IVTXA
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only researchers designated on the IRB study application will be allowed to access patient data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
- ClinicalTrials.gov ID
- NCT05794321
- Acronym / sponsor ID
- IVTXA / 23-38580
- Conditions
- Postoperative Hematoma, Postoperative Seroma
- Keywords
- Gender Affirming Mastectomy, Tranexamic Acid, IV TXA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 3 Apr 2023 (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.
Gender affirming surgeries (GAS) have been steadily increasing in the US, with the gender affirming mastectomy (GAM) being the most common surgery performed. Complications associated with these surgeries include hematoma and seroma. Prior studies in orthopedics, plastic surgery, and trauma have shown significant reduction of bleeding and ecchymosis with the use of tranexamic acid (TXA). TXA is a synthetic amino acid that blocks plasminogen conversion to plasmin, to stabilize clot formation. The intravenous (IV) efficacy in reducing hematoma rates has been established in implant-based breast reconstruction, as well as in reduction mammaplasty. However, there are currently no studies investigating the use of IV TXA in patients undergoing GAM.
The investigators propose a single-center, prospective randomized control trial to evaluate the efficacy and safety of intravenous tranexamic acid in decreasing hematoma and seroma rates for top surgery patients at UCSF. Patients will be randomized into two groups, an experimental group receiving IV TXA and a control group that will not receive IV TXA.
Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Patients will be excluded if they have a history of coagulopathy, bleeding disorders or prior chest surgery. Demographic data, surgical characteristics, and postoperative outcomes will also be recorded and analyzed. The investigators hypothesize that the use of IV TXA will significantly reduce hematoma, seroma, postoperative drain output, and time to drain removal in patients undergoing GAM.
Aim 1: To evaluate the effectiveness of IV TXA in reducing intraoperative bleeding, post-operative hematoma and seroma formation, drain output, and time to drain removal in patients undergoing GAM.
Aim 2: To compare the incidence of thromboembolic events and wound complications between patients receiving IV TXA and those who do not after GAM.
Detailed description
This is a prospective, randomized, controlled single-surgeon trial performed at the University of California San Francisco that investigates the use of IV TXA in patients undergoing GAM. All patients who meet WPATH guidelines for GAM, undergo GAM, ASA I-III, and are >18 years old will have the opportunity to be enrolled. Patients will be randomized by a random computer generator and will be notified after randomization as to which group they are assigned.
The investigators will enroll patients into this prospective trial investigating the effect of IV TXA on postoperative bleeding, hematoma, seroma, drain output, and time to drain removal. Patients will be randomized into two groups, an experimental group receiving IV TXA and a control group that will not receive IV TXA. Patients will be excluded if they are <18 years old, have a history of prior chest surgeries, coagulopathy or bleeding disorders, and have a history of thromboembolic events including deep vein thrombosis or pulmonary embolism. Patients will also be excluded if they are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
All patients who are being scheduled to undergo bilateral mastectomy with immediate reconstruction will be recruited to participate in the study. Patients will be consented to participate in the preoperative visit.
Experimental Group: Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Postoperative care will be standard and based on established UCSF guidelines.
Control Group: Patients in the control group will not receive any TXA intraoperatively and will undergo a traditional GAM.
Tranexamic Acid is available as a sterile, single-dose. This 1g vial is readily available in the anesthesia cart in the operating room. Immediately following induction, the anesthesia team will administer 1g of TXA intravenously. After obtaining hemostasis and irrigating as per standard practice, anesthesia shall not use any other hemostatic agents.
Post-procedure, each patient will be provided with standard postoperative instructions which will include a chart to record daily drain outputs for the right and left sides. At subsequent postoperative visits, drain output will be assessed at each clinic visit to determine timing for removal. The total drain output will be measured by the patient and later logged into our chart for later analysis. Drains will be removed per standard practice at our institution which is when they have produced < 30cc/day for at least 3 days.
At each clinic visit, the investigators will assess for clinical signs of hematoma and seroma, and objectively measure aggregate drain output. Demographic data, surgical characteristics, and postoperative outcomes such as hematoma, seroma, drain output, wound complications, surgical site infections, and thromboembolic events will be recorded and analyzed. These outcomes will be evaluated in the immediate 3-month postoperative period, with a 1-year follow-up review of patient charts. The primary outcomes will include the presence of hematoma, seroma, and drain output, and time to drain removal, while the secondary outcomes will consist of thromboembolic events and wound complications.
Patients will be managed for hematoma and seroma as per standard procedure, whether with ultrasound, clinic aspiration, IR drain placement, or return to the operating room as deemed necessary by the senior surgeon.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to treatment arms. One treatment arm will include the use of IV TXA, the other treatment arm will receive the standard of care for treatment. Patients then remain in that same treatment arm throughout the course of the study
| Arm | Type | Receives |
|---|---|---|
| IV TXA Group | Experimental | Drug: Intravenous TXAPatients in the experimental group will receive a loading dose of IV tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Postoperative care will be standard and based on established UCSF guidelines. |
| Control Group | No intervention | –Patients in the control group will not receive any IV TXA intraoperatively and will undergo a traditional gender affirming mastectomy following the established standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years of age
- All patients who undergo gender affirming mastectomy at UCSF
- ASA I-III,
- Ability to understand a written informed consent document, and the willingness to sign it.
- Patients who fulfil WPATH guidelines/criteria for undergoing GAM. WPATH Criteria include: Persistent, well-documented gender dysphoria; capacity to make a fully informed decision and to consent for treatment; age of majority in a given country; if significant medical or mental health concerns are present, they must be reasonably well controlled; 12 continuous months of hormone therapy as appropriate to the patient's gender goals (for two referrals by a mental health professional).
Key exclusion criteria (8 listed)
- <18 years old
- Unable to consent for themselves
- History of coagulopathy or bleeding disorders
- History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
- Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
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 |
|---|---|---|
| Intravenous TXAPatients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. | Drug | IV TXA Group |
Primary outcome
Number of Participants with Clinically Significant Hematomas
Time frame: Up to 3 months
Hematoma will be defined as a collection of blood outside of blood vessels that requires intervention such as aspiration or surgical drainage. Hematomas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for hematoma formation. Patients who develop symptoms of hematoma after discharge will be instructed to seek medical attention immediately. Hematoma will be assessed immediately after mastectomy, and then at their one week postoperative clinic visit. Patients will also be instructed to report any symptoms of hematoma to their healthcare provider after discharge. Data on hematoma will be collected as a binary outcome (yes/no), as well as the size of the hematoma and type of intervention. Statistical analysis will be used to determine the factors associated with hematoma development after mastectomy.
Number of Participants with Clinically Significant Seromas
Time frame: Up to 3 months
Seroma will be defined as a collection of fluid that accumulates in the surgical site after mastectomy that requires intervention such as aspiration or surgical drainage. Seromas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for seroma formation. Seroma will be assessed immediately after mastectomy, and then at their one postoperative clinic visit. Patients will also be instructed to report any symptoms of seroma to their healthcare provider after discharge. Data on seroma will be collected as a binary outcome (yes/no), as well as the type of intervention, and the duration of symptoms. Statistical analysis will be used to determine the factors associated with seroma development after mastectomy.
Total Patient Drain Output
Time frame: Up to 3 months
Drain output will be defined as the amount of fluid (in milliliters) collected in surgical drains after mastectomy. The volume of fluid collected will be recorded by patients daily until the drains are removed. All patients will have surgical drains placed after mastectomy. Patients will be instructed to report any unusual drainage or bleeding to their healthcare provider. Data on drain output will be collected as a continuous variable, as well as the duration of drain placement. Statistical analysis will be used to determine the factors associated with increased drain output after mastectomy.
Time to Drain Removal
Time frame: Up to 3 months
Time to drain removal will be defined as the number of days from mastectomy surgery to the day the surgical drains are removed. The timing of drain removal will be determined by the primary surgeon, based on the amount and character of fluid collected in the drain, and the presence of factors such as infection, hematoma, or seroma. However, drains will typically be removed when they have produced < 30cc/day for at least 3 days. The timing of drain removal will be recorded by nursing staff at the time of removal. Data on time to drain removal will be collected as a continuous variable, as well as the reason for early or delayed drain removal. Statistical analysis will be used to determine the factors associated with longer time to drain removal after mastectomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Gender-Affirming Mastectomy in Transmasculine PatientsLink provided by the sponsor.
- Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trialLink provided by the sponsor.
- Early Postoperative Outcomes of Breast Cancer Surgery in a Developing CountryLink provided by the sponsor.
- The Use of Hemostatic Agents to Decrease Bleeding Complications in Breast Cancer SurgeryLink provided by the sponsor.
- U.S. Sex Reassignment Surgery Market Size, Share \& Trends Analysis Report by Gender Transition (Male To Female, Female To Male), and Segment Forecasts, 2022-2030Link provided by the sponsor.
- Efficacy of Tranexamic Acid in Reducing Seroma and Hematoma Formation Following Reduction MammaplastyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only researchers designated on the IRB study application will be allowed to access patient data.
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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.
Esther Kim, MD principal investigator
UCSF Department of Plastic & Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous TXA in people with Postoperative Hematoma and Postoperative Seroma, run by University of California, San Francisco 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan S Ramrakhiani, BS (6507760834, nathan.ramrakhiani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Clinically Significant Hematomas (time frame: Up to 3 months). The study lists 4 primary outcomes in all. 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 4 Jun 2026.