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

Trial Summary

What is the purpose of this trial?

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.

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 tranexamic acid safe for use in humans?

Tranexamic acid is generally considered safe for use in humans, with studies showing no toxic effects on the liver, kidney, or heart, and no side effects in patients with bleeding disorders. However, it may increase the risk of seizures in cardiac surgery. ^{1 2 3 4 5}

How does the drug tranexamic acid differ from other treatments for facelift surgery?

Tranexamic acid is unique in facelift surgery because it reduces bleeding and swelling by preventing the breakdown of blood clots, leading to a drier surgical field and shorter operating times, which is not a standard feature of other treatments. ^{2 4 5 6 7}

Research Team

Friederike Luetzenberg,, MD

Principal Investigator

University of Minnesota

Jenna Van Beck, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

I speak English.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. Switzerland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Efficacy and Safety of Tranexamic Acid in Facelift Surgery. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid in control of haemorrhage after dental extraction in haemophilia and Christmas disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid With Local Anesthetic Reduces Intraoperative Facelift Bleeding: A Preliminary Report. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid During Facelift Improves Operating Room Efficiency: A Matched Patient Study. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Prophylaxis in Hip and Knee Joint Replacement. [2018]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The efficacy and safety of tranexamic acid and epsilon-aminocapronic acid in cardiac surgery under extracorporeal circulation]. [2013]