Tranexamic Acid for Facelift Surgery

Overseen By Jenna Van Beck, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Under 18, Adverse TXA reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day (surgery day)

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tranexamic acid (TXA) to determine its effectiveness in reducing bleeding during facelift surgeries. Researchers apply TXA to one side of the face and a saline solution to the other side for comparison. The study includes three treatment groups, each using different TXA mixtures. Individuals planning to have a facelift and without a history of adverse reactions to TXA may be suitable candidates for this trial. As an Early Phase 1 trial, this research aims to understand how TXA works in people, offering participants an opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves topical application of tranexamic acid, it is less likely to interact with other medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tranexamic acid (TXA) is safe for use in facelift surgeries. One study found that TXA reduced bleeding during surgery without increasing complications. Another review confirmed that TXA did not cause problems with wound healing, even when applied directly to the face.

TXA has been safely used in other types of surgeries for many years. When applied directly to the skin or a specific area, it does not carry the same risks as intravenous administration, such as blood clots. Previous studies have not reported any negative side effects from using TXA in facial plastic surgery.

Overall, TXA appears to be a safe choice for reducing bleeding in facelift procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about tranexamic acid (TXA) for facelift surgery because it offers a unique approach to reducing bleeding and bruising, which are common concerns with this procedure. Unlike traditional methods that may rely on careful surgical technique and compression garments, TXA works by stabilizing blood clots, thereby potentially minimizing blood loss and improving recovery time. The trial explores different ways to administer TXA—whether mixed with standard local anesthetics or applied directly with soaked pledgets—each aimed at enhancing its effectiveness. This versatility and the potential for improved surgical outcomes make TXA a promising candidate for facelift operations.

What evidence suggests that this trial's treatments could be effective for facelift surgery?

Research shows that tranexamic acid (TXA) reduces bleeding and bruising during and after facelift surgery. In this trial, participants will receive different TXA treatments on each side of their face, serving as their own control. Studies have found that TXA significantly decreases blood loss during surgery and reduces swelling and bruising afterward. For instance, TXA lowers the amount of fluid collected in surgical drains and reduces small blood clots under the skin. Importantly, TXA achieves this without increasing the risk of major complications. Safety data indicates that using TXA directly on the face during surgery avoids the risk of side effects throughout the body. Overall, these findings suggest that TXA is a promising option for managing bleeding in facial surgeries. ^{2 4 6 7 8}

Who Is on the Research Team?

Friederike Luetzenberg,, MD

Principal Investigator

University of Minnesota

Jenna Van Beck, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults over 18 who choose to have a facelift and are considered fit for the surgery by their doctor. It includes those having additional procedures, but participants must speak English.

Inclusion Criteria

I speak English.

I am a regular patient at the clinic and have been approved by the surgeon for facelift surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

TXA is applied to a randomly assigned side of the face during facelift surgery, with different concentrations and methods for each treatment group

1 day (surgery day)

1 visit (in-person)

Follow-up

Participants are monitored for blood loss and adverse effects such as flap epidermolysis, hair loss, or abnormal scar formation

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid

Trial Overview The study tests Tranexamic acid (TXA) applied during facelifts to reduce bleeding. There are three ways TXA will be used: mixed with standard local anesthetic, as a higher concentration on soaked pledgets, or both methods combined.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

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.

Group II: Group 2 Experimental Treatment 1 Intervention

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.

Group III: Group 1 Experimental Treatment 1 Intervention

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.

Tranexamic acid is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Lysteda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma

Approved in European Union as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Approved in Japan as Nicolda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 27 female patients undergoing facelift surgery, the local infiltration of tranexamic acid (TXA) combined with lidocaine significantly reduced the time needed to achieve hemostasis, averaging around 6.5 minutes per side, which can save approximately 25 to 60 minutes of total surgical time.

The use of TXA not only decreased bleeding during the procedure but also resulted in less postoperative drainage, suggesting it enhances safety and efficacy in facelift surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid With Local Anesthetic Reduces Intraoperative Facelift Bleeding: A Preliminary Report. Couto, RA., Charafeddine, A., Sinclair, NR., et al.[2021]

Prophylactic administration of tranexamic acid (TXA) before major hip and knee surgeries significantly reduces intra- and postoperative bleeding and the need for blood transfusions, with a number needed to treat (NNT) of 3.7-5.7 for knee replacements and 4.1-8.2 for hip replacements.

The use of TXA does not significantly increase the risk of thromboembolic events compared to placebo, and while there is limited data on the risk of seizures, the doses used in these surgeries are unlikely to cause such complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Prophylaxis in Hip and Knee Joint Replacement. Goldstein, M., Feldmann, C., Wulf, H., et al.[2018]

In a study of 145 patients undergoing facelift surgery, the use of tranexamic acid (TXA) significantly reduced surgical time by an average of 21 minutes compared to those who did not receive TXA.

The study found no increase in minor or major complications associated with the use of TXA, suggesting it is a safe option that enhances efficiency in aesthetic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid During Facelift Improves Operating Room Efficiency: A Matched Patient Study. Coombs, DM., Kwiecien, GJ., Sinclair, NR., et al.[2023]

Tranexamic acid (TXA) is effective in reducing blood loss and the need for blood transfusions across various types of surgeries, including orthopedic and cardiac procedures, based on a systematic review of 47 meta-analyses involving numerous outcomes.

TXA is generally safe, showing no increase in death or vascular adverse events, although it may pose a risk for seizures in cardiac surgery, highlighting the need for tailored dosing recommendations for different surgical types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Tranexamic Acid Reduce the Blood Loss in Various Surgeries? An Umbrella Review of State-of-the-Art Meta-Analysis. Hong, P., Liu, R., Rai, S., et al.[2022]

In a study of 60 patients undergoing heart surgery with extracorporeal circulation, tranexamic acid (TA) demonstrated four times more antifibrinolytic activity compared to epsilon-aminocapronic acid (ACA), leading to significantly reduced blood loss during and after surgery.

Patients receiving TA experienced fewer complications and required less donor blood transfusion, suggesting that TA is a safer and more effective option for minimizing blood loss in cardiosurgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy and safety of tranexamic acid and epsilon-aminocapronic acid in cardiac surgery under extracorporeal circulation]. Iavorovskiĭ, AG., Ziuliaeva, TP., Charnaia, MA., et al.[2013]

Tranexamic acid (TXA) significantly reduces postoperative complications such as serosanguineous collections, ecchymosis, and bruising in facelift surgery, based on a review of 3 studies involving 150 patients.

TXA also leads to lower intraoperative blood loss and reduced drainage output in the first 24 hours post-surgery, indicating its efficacy in improving clinical outcomes, although more high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Efficacy and Safety of Tranexamic Acid in Facelift Surgery. Al-Hashimi, M., Kaur, P., Charles, W., et al.[2023]

In a double-blind trial involving patients with hemophilia and Christmas disease, tranexamic acid (1 g three times a day for five days) significantly reduced blood loss and the need for blood transfusions after dental extractions.

The study found no side effects or toxic effects on the liver, kidney, or heart, indicating that tranexamic acid is a safe option for managing bleeding in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid in control of haemorrhage after dental extraction in haemophilia and Christmas disease. Forbes, CD., Barr, RD., Reid, G., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39141514/

Impact of Tranexamic Acid on Bleeding Outcomes and ... Conclusions: TXA significantly reduces postoperative drain output and minor hematomas in facelift surgery without increasing major complications ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10553119/

Tranexamic acid in rhytidectomy: a scoping review - PMC Consequently, TXA is often recommended for facelift procedures as it can help reduce bleeding and bruising during and after the surgery. But, actually, the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525002074

Evaluation of the safety and efficacy of tranexamic acid use ... TXA demonstrated promising results in facial surgery by reducing intraoperative bleeding and time, postoperative ecchymosis, edema, and drain output. Although ...

4. jprasurg.com jprasurg.com/article/S1748-6815(24)00639-9/fulltext

Role of tranexamic acid (TXA) in plastic and reconstructive ... The most common procedures performed under TXA were facial procedures, including facelift (83.6%), neck lift (77.1%), forehead and browlift ( ...

5. liebertpub.com liebertpub.com/doi/10.1089/fpsam.2024.0008

Tranexamic Acid in Rhytidectomy: A Split-Face Multi- ... The use of tranexamic acid in local anesthetic prior to facelift surgery can potentially decrease postoperative bruising.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10923354/

Safety and Outcomes in Multiplane Facial Rejuvenation ... In conclusion, the use of TXA is safe and improves the short- and long-term outcomes of patients who undergo multiplane facial rhytidectomy.

7. journals.lww.com journals.lww.com/prsgo/fulltext/2024/03000/safety_and_outcomes_in_multiplane_facial.22.aspx

Safety and Outcomes in Multiplane Facial Rejuvenation ... Findings: The TXA group showed less intraoperative bleeding; shorter operative time; and less ecchymosis, edema, and time to drain removal.

8. academic.oup.com academic.oup.com/asj/advance-article/doi/10.1093/asj/sjaf130/8185680

Local Tranexamic Acid in Facelift Surgery Is Not Associated ... Local administration of TXA in a concentration of 1 to 2 mg/mL is not associated with an increased risk for minor or major wound healing ...