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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tranexamic acid to determine if it reduces bleeding, bruising, and swelling during and after nose surgery (rhinoplasty). The study will compare outcomes between patients receiving tranexamic acid and those receiving routine care without it. It targets adults planning rhinoplasty with bone repositioning and no other simultaneous facial surgeries. Participants should not have a history of blood disorders, severe kidney problems, or be on blood thinners. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?

Research shows that tranexamic acid (TXA) is generally safe for use during surgeries like nose jobs. Studies have found that it reduces blood loss without causing serious side effects. For example, one study found that using TXA during surgery led to less blood loss compared to not using it. Another study showed that TXA helped reduce swelling and bruising after surgery. Importantly, no reports have indicated serious problems when TXA is given in one to three doses around the time of surgery. This makes TXA a promising option for controlling bleeding during and after procedures like nose jobs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment options for postoperative hemorrhage in rhinoplasty, which often involve nasal packing or electrocautery, tranexamic acid stands out because it directly targets blood clotting. This medication works by preventing the breakdown of fibrin, a protein that helps form blood clots, thereby reducing bleeding. Researchers are excited about tranexamic acid because it could offer a more precise and less invasive way to manage bleeding, potentially leading to faster recovery and fewer complications post-surgery.

What evidence suggests that tranexamic acid might be an effective treatment for postoperative hemorrhage in rhinoplasty?

In this trial, participants will either receive tranexamic acid (TXA) or undergo routine care without it. Research has shown that TXA can reduce blood loss during surgeries like nose jobs. Studies have found that TXA can decrease bleeding, swelling, and bruising after surgery, and it also improves visibility for surgeons during operations. However, one study found no difference in bleeding or swelling with TXA, indicating that results can vary. Overall, many surgeons report high satisfaction with its use in these procedures. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40449323/

Impact of tranexamic acid on postoperative complications ... Results: Twenty-two studies involving 9005 patients were included. TXA significantly reduced blood loss, postoperative edema, and ecchymosis. The average ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11537566/

Tranexamic Acid in Rhinoplasty and Septoplasty The findings support TXA's efficacy in reducing blood loss during rhinoplasty and septoplasty, with high surgeon satisfaction. Takeaways.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824000664

Comparative Study of the Effects of Clonidine and ... To control bleeding during the surgery in patients undergoing rhinoplasty, TXA use resulted in reduced blood loss and a better surgical field quality compared ...

4. liebertpub.com liebertpub.com/doi/10.1089/fpsam.2024.0327

Intravenous Tranexamic Acid in Rhinoplasty Conclusions: In this study, there was no difference in bleeding, edema, ecchymosis, or postoperative experience associated with TXA.

5. nature.com nature.com/articles/s41598-025-07450-3

Comparing the effect of pre-anesthesia clonidine and ... This study aims to evaluate the effectiveness of clonidine and TXA drugs separately in controlling bleeding during rhinoplasty performed under ...

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

Evaluation of the safety and efficacy of tranexamic acid use ... TXA significantly reduced postoperative edema in 1 of 2 studies (p < 0.05). Procedure time was either unchanged or reduced. Drainage output and days before ...

7. trialx.com trialx.com/clinical-trials/listings/262663/tranexamic-acid-in-rhinoplasty-perioperative-bleeding-edema-and-ecchymosis/?&radius=50

Tranexamic Acid in Rhinoplasty: Perioperative Bleeding ... In these studies, TXA has been given in intravenous and/or oral form in 1-3 doses in the perioperative period, and there have been no serious ...