Tranexamic Acid for Postoperative Hemorrhage in Rhinoplasty Surgery

Overseen By Jaclyn Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Thromboembolism, Renal impairment, Coagulation disorder, 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: 2

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be a prospective randomized study to evaluate the effect of tranexamic acid (TXA) use on intraoperative and postoperative outcomes among patients undergoing rhinoplasty by two Facial Plastic surgeons at Vanderbilt. Outcomes will include intra- and post-operative bleeding and postoperative bruising and swelling.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are currently using anticoagulants (blood thinners).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on blood thinners, you cannot participate. It's best to discuss your medications with the trial team.

What data supports the idea that Tranexamic Acid for Postoperative Hemorrhage in Rhinoplasty Surgery is an effective drug?

The available research shows that Tranexamic Acid is effective in reducing blood loss during and after rhinoplasty surgery. Several studies, including systematic reviews and randomized trials, indicate that this drug helps control bleeding, which is a major complication in these surgeries. It also reduces swelling and bruising around the eyes after the surgery. Compared to other treatments, Tranexamic Acid appears to be effective in minimizing these common postoperative issues. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Tranexamic Acid for reducing postoperative hemorrhage in rhinoplasty surgery?

Research shows that Tranexamic Acid is effective in reducing blood loss and complications like swelling and bruising after rhinoplasty surgery. ^{1 2 3 4 5}

What safety data exists for tranexamic acid in rhinoplasty surgery?

The safety data for tranexamic acid (TXA) in rhinoplasty surgery is mixed. One study mentions potential serious side effects such as seizures, blood clots, and vision changes, but reports no adverse events in their trial. Another study indicates that there is not enough evidence to conclusively judge the safety of TXA in nasal surgeries, including rhinoplasty. Overall, while TXA is used to reduce bleeding, its safety profile in this context requires further evaluation. ^{1 3 4 6 7}

Is tranexamic acid safe for use in humans?

Tranexamic acid (TXA) is generally considered safe, but it may have serious side effects like seizures, blood clots, and vision changes. In a study involving rhinoplasty patients, no adverse events were reported with TXA use. ^{1 3 4 6 7}

Is the drug Tranexamic acid a promising treatment for reducing bleeding after rhinoplasty surgery?

Yes, Tranexamic acid is a promising drug for reducing bleeding after rhinoplasty surgery. Research shows it helps control blood loss and reduces complications like swelling and bruising around the eyes. ^{1 2 3 4 5}

How does the drug tranexamic acid differ from other treatments for postoperative hemorrhage in rhinoplasty surgery?

Tranexamic acid is unique because it is an antifibrinolytic drug, meaning it helps prevent the breakdown of blood clots, which reduces bleeding during and after surgery. This makes it particularly effective in controlling blood loss and minimizing complications like swelling and bruising after rhinoplasty, compared to other treatments that may not specifically target blood clot stability. ^{1 2 3 4 5}

Research Team

Shiayin F Yang, MD

Principal Investigator

Vanderbilt University Medical Center

Jaclyn S Lee, MD

Principal Investigator

Vanderbilt University Medical Center

Alexander J Barna, MPH

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults over 18 ready for primary rhinoplasty without other facial or sinus surgeries. Candidates must not have bleeding disorders, low platelets, be on blood thinners, have uncontrolled diabetes, heart issues like arrhythmia or past heart attacks, strokes, seizures, liver failure; color vision defects; history of clots; allergy to TXA; brain bleeds; severe kidney disease or active clotting conditions.

Inclusion Criteria

Lack all the below Exclusion Criteria

I have not had any other facial or sinus surgery at the same time.

I am over 18 and choosing to have a nose surgery for cosmetic or functional reasons by Drs. Yang or Patel at VUMC.

Exclusion Criteria

You have low platelet count (<150,000).

I have an active blood clotting disorder.

You have color vision problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Participants receive either 1 gram IV tranexamic acid or placebo in the operating room prior to surgical incision

During surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative bleeding, ecchymosis, and edema up to one week following surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tranexamic acid

Trial Overview The study tests if tranexamic acid (TXA) can reduce bleeding during and after nose surgery (rhinoplasty), as well as lessen post-surgery bruising and swelling. It's a forward-looking study where patients are randomly chosen to receive TXA and their surgical outcomes are compared.

Participant Groups

Group I: Tranexamic Acid Experimental Treatment 1 Intervention

Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.

Group II: Control Active Control 1 Intervention

Routine care, no tranexamic acid given.

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?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

In a randomized placebo-controlled trial involving 80 patients, Tranexamic acid (TXA) did not significantly reduce intraoperative blood loss during rhinoplasty compared to a placebo, with a mean difference of -3.6 mL (P = 0.65).

Surgeon satisfaction regarding the quality of the surgical field was also not significantly improved with TXA, showing a mean difference of 0.18 (P = 0.22), indicating that TXA may not provide the expected benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-Evaluating the Effect of Preoperative Tranexamic Acid on Blood Loss and Field Quality During Rhinoplasty: A Randomized Double-Blinded Controlled Trial. Afzali, SL., Panahi, H., Ganji, F., et al.[2022]

Tranexamic acid significantly reduces intraoperative blood loss and the duration of surgery in nasal procedures, based on a meta-analysis of 16 randomized clinical trials involving 1108 patients.

The study found a low risk of bias across the trials, and the evidence supporting the efficacy of tranexamic acid was rated high according to the GRADE system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid in bleeding reduction and operative time of nasal surgeries: systematic review and meta-analysis. Goncalves, PE., Ferreira, FJS., Lima, AS., et al.[2023]

Tranexamic acid significantly reduces intraoperative bleeding during rhinoplasty, with a weighted mean difference of -42.28 mL, indicating its efficacy in managing blood loss during surgery.

The use of tranexamic acid also leads to lower postoperative eyelid edema and ecchymosis, with significant reductions observed in the first week after surgery, and no thromboembolic events were reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Tranexamic Acid for Treatment of Bleeding, Edema, and Ecchymosis in Patients Undergoing Rhinoplasty: A Systematic Review and Meta-analysis. de Vasconcellos, SJA., do Nascimento-Júnior, EM., de Aguiar Menezes, MV., et al.[2019]

Tranexamic acid (TXA) significantly reduces perioperative blood loss and improves surgical field quality during nasal surgeries, based on a meta-analysis of 11 randomized controlled trials.

TXA also helps decrease eyelid edema and ecchymosis after surgery, but it does not significantly affect the duration of the surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial. Ping, WD., Zhao, QM., Sun, HF., et al.[2022]

In a study of 50 rhinoplasty patients, administering 10 mg/kg of Tranexamic acid (TXA) significantly reduced intraoperative bleeding compared to the control group, with an average of 213 mL versus 254 mL (P = 0.013).

TXA also significantly decreased postoperative eyelid edema and periorbital ecchymosis, leading to higher surgeon satisfaction, indicating its efficacy and safety in enhancing recovery after rhinoplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tranexamic acid on side effects of rhinoplasty: A randomized double-blind study. Ghavimi, MA., Taheri Talesh, K., Ghoreishizadeh, A., et al.[2018]

In a study involving 100 primary rhinoplasty patients, tranexamic acid (TXA) did not significantly reduce postoperative ecchymosis compared to a control group, as measured by objective color scales.

There were no adverse events reported with the use of TXA, indicating it may be safe to use, but its efficacy in reducing bruising after rhinoplasty is questionable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Tranexamic Acid Effects on Ecchymosis in Rhinoplasty. Cristel, RT., Demesh, D., Patel, MJ., et al.[2022]

In a study of 400 patients undergoing nasal surgery, those who received tranexamic acid (TA) experienced significantly less bleeding during and after the procedure compared to those who did not receive the medication.

TA was found to be safe, with minimal adverse reactions that resolved after treatment, and it may be recommended for routine use to reduce bleeding complications in nasal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemostatic effect of tranexamic acid in elective nasal surgery. Yaniv, E., Shvero, J., Hadar, T.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Re-Evaluating the Effect of Preoperative Tranexamic Acid on Blood Loss and Field Quality During Rhinoplasty: A Randomized Double-Blinded Controlled Trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Tranexamic acid in bleeding reduction and operative time of nasal surgeries: systematic review and meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Preoperative Tranexamic Acid for Treatment of Bleeding, Edema, and Ecchymosis in Patients Undergoing Rhinoplasty: A Systematic Review and Meta-analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Efficacy of tranexamic acid on side effects of rhinoplasty: A randomized double-blind study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Tranexamic Acid Effects on Ecchymosis in Rhinoplasty. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Hemostatic effect of tranexamic acid in elective nasal surgery. [2014]