HemophiliaEarly Phase 1NCT06345833
Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study
A Early Phase 1 study testing 1%Tranexamic acid with standard local, 3% TXA and 1% TXA with local plus 3% TXA-soaked pledgets in people with Hemophilia and Hemorrhage, run by University of Minnesota at 1 site in United States.
Trial summary
Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia, Hemorrhage, Facelift Surgery
- What is being tested?
- 1%Tranexamic acid with standard local, 3% TXA and 1% TXA with local plus 3% TXA-soaked pledgets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures
- age 18 and older
- English speaking.
Who cannot join
- younger than 18
- previously had an adverse reaction to tranexamic acid
- non-English speaking
- patients who elect not to participate or withdraw from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.
Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.[12] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.
- Conditions
- Hemophilia, Hemorrhage, Facelift Surgery
- Being tested
- 1%Tranexamic acid with standard local, 3% TXA, 1% TXA with local plus 3% TXA-soaked pledgets
- Medical subject headings
- Hemophilia A, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1%Tranexamic acid with standard localDrug
1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control.
3% TXADrug
3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control.
1% TXA with local plus 3% TXA-soaked pledgetsDrug
1% TXA with local plus 3% TXA-soaked pledgets with saline as the control.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control.
Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control. Receives: Drug: 1%Tranexamic acid with standard local |
| Group 2 | Experimental | 3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control
Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control. Receives: Drug: 3% TXA |
| Group 3 | Experimental | 1% TXA with local plus 3% TXA-soaked pledgets with saline as the control
Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control. Receives: Drug: 1% TXA with local plus 3% TXA-soaked pledgets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
measured through post-operative drain output, post-operative edema and ecchymosis.
drain output is believed to be a more accurate representation of blood loss as it directly assesses the area in which TXA was applied as compared to intra-operative blood loss, which would be heavily influenced by bleeding from the skin incision.
Measured: 2 weeks post-op
Secondary outcomes (1)
adverse effects of TXA rates
in the form of flap epidermolysis, hair loss, or abnormal scar formation (e.g. hypertrophic scars) at the incision sites post-operatively.
Measured: 2 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Why it stopped: Lack of Participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenna Van Beck, MD, Principal investigator, University of MinnesotaFriederike Luetzenberg,, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345833
- Sponsor's protocol ID
- ENT-2024-32847
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study
- ClinicalTrials.gov ID
- NCT06345833
- Acronym / sponsor ID
- ENT-2024-32847
- Conditions
- Hemophilia, Hemorrhage, Facelift Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Apr 2024 (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.
Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.
Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.[12] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: 1%Tranexamic acid with standard local1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control. Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control. |
| Group 2 | Experimental | Drug: 3% TXA3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control. |
| Group 3 | Experimental | Drug: 1% TXA with local plus 3% TXA-soaked pledgets1% TXA with local plus 3% TXA-soaked pledgets with saline as the control Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures
- age 18 and older
- English speaking.
Key exclusion criteria (4 listed)
- younger than 18
- previously had an adverse reaction to tranexamic acid
- non-English speaking
- patients who elect not to participate or withdraw from the study.
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 |
|---|---|---|
| 1%Tranexamic acid with standard local1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control. | Drug | Group 1 |
| 3% TXA3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control. | Drug | Group 2 |
| 1% TXA with local plus 3% TXA-soaked pledgets1% TXA with local plus 3% TXA-soaked pledgets with saline as the control. | Drug | Group 3 |
Primary outcome
Blood loss
Time frame: 2 weeks post-op
measured through post-operative drain output, post-operative edema and ecchymosis. drain output is believed to be a more accurate representation of blood loss as it directly assesses the area in which TXA was applied as compared to intra-operative blood loss, which would be heavily influenced by bleeding from the skin incision.
1 secondary outcome
adverse effects of TXA rates
Time frame: 2 weeks 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 23 Jul 2026.
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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.
Jenna Van Beck, MD principal investigator
University of Minnesota
Friederike Luetzenberg,, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 1%Tranexamic acid with standard local, 3% TXA and 1% TXA with local plus 3% TXA-soaked pledgets in people with Hemophilia and Hemorrhage, run by University of Minnesota 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 3 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 23 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Blood loss (time frame: 2 weeks 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 23 Jul 2026.