Tranexamic Acid for Swollen Eyes

Not currently recruiting at 1 trial location

Overseen By Troy Karanfilian

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Previous orbital surgery, Stroke, Seizure, others

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tranexamic acid to determine its effectiveness in reducing swelling and bruising around the eyes after orbital surgery. There are two main treatment groups: one receives tranexamic acid (a medication used to reduce bleeding) through an IV before surgery, and another receives it locally mixed with anesthesia. A control group receives the usual treatment without the drug. Suitable participants have not had previous orbital surgery and will undergo procedures like decompressions or fracture repairs. Those with a history of stroke, seizure, active infection, or who are on blood thinners may not qualify for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Will I have to stop taking my current medications?

You will need to stop taking any anticoagulant or antiplatelet medications, including aspirin, at least 7 days before the surgery.

What is the safety track record for tranexamic acid?

Research has shown that tranexamic acid (TXA) is generally safe for people. Studies have found that administering TXA through an IV can significantly reduce bleeding during surgery without causing major side effects. For example, one study showed that a high initial dose of TXA effectively reduced blood loss and the need for blood transfusions.

When used locally, research suggests that TXA is safe and effective when injected under the skin. It has been found to reduce swelling and bruising around the eyes with minimal risk of serious side effects. Another study confirmed that local TXA significantly reduced eyelid swelling without causing major problems.

Overall, both IV and local TXA treatments have been well-tolerated in past studies, showing promise in safely reducing bleeding and swelling. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tranexamic acid is unique for treating swollen eyes because it works to stabilize blood clots by preventing the breakdown of fibrin, which is a different approach compared to typical anti-inflammatory medications or surgical interventions. Researchers are excited about two delivery methods being tested: an intravenous (IV) method and a local subcutaneous injection mixed with anesthetic. The IV approach allows for quick systemic action, while the local injection directly targets the surgical area, potentially reducing swelling and bruising with precision. This dual approach could offer more efficient and targeted treatment options compared to standard care.

What evidence suggests that tranexamic acid might be an effective treatment for swollen eyes?

Research shows that tranexamic acid (TXA) can reduce bruising and swelling after surgery. In this trial, participants will join different treatment arms to evaluate TXA's effects. Group 1 will receive intravenous (IV) TXA, which studies have shown reduces blood loss and significantly lessens bruising by the eighth day after surgery. Group 2 will receive local TXA injections, which have been found to reduce swelling and bruising compared to placebo injections. Group 3 will serve as the control group, receiving placebo injections. These findings suggest that TXA, whether given by IV or as a local injection, may speed up recovery and improve cosmetic results after eye-related surgeries. ^{1 5 6 7 8}

Who Is on the Research Team?

Anne Barmettler

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and are undergoing orbital surgery, like decompressions or fracture repairs. It's not suitable for those unable to give consent or meet the inclusion criteria.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I am having surgery on my eye socket.

Exclusion Criteria

I am having more than one eye surgery at the same time.

I have not taken blood thinners, including aspirin, in the week before surgery.

Any patient with active infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants are randomly allocated to treatment groups and receive either intravenous or subcutaneous tranexamic acid or placebo prior to surgery

1 day

1 visit (in-person)

Postoperative Assessment

Standardized photographs are taken immediately after surgery and at the 7-day postoperative visit to assess ecchymosis and edema

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of patient satisfaction and side effects

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid

Trial Overview The study tests if Tranexamic acid (TXA), given locally or systemically, reduces swelling and bruising after orbital surgery compared to normal saline solutions.

How Is the Trial Designed?

Group I: Group 2: Local TXA Experimental Treatment 2 Interventions

1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision

Group II: Group 1: IV TXA Experimental Treatment 2 Interventions

1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery

Group III: Group 3: Control Placebo Group 2 Interventions

Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group

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?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

A high initial dose of 60 mg/kg intravenous tranexamic acid (IV-TXA) significantly reduced peri-operative blood loss and transfusion rates in 132 patients undergoing total knee arthroplasty compared to a lower dose of 20 mg/kg.

Patients receiving the higher dose also experienced lower levels of inflammatory markers and pain in the days following surgery, while maintaining similar coagulation parameters and complication rates as those on the lower dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial. Lei, YT., Xie, JW., Huang, Q., et al.[2021]

Intraoperative injection of tranexamic acid (TXA) during total knee arthroplasty (TKA) significantly reduced postoperative blood loss and the need for blood transfusions, as shown in a study of 100 patients.

The TXA group experienced lower drainage volumes and milder ecchymosis compared to the control group, indicating that TXA is both effective and safe for minimizing hemorrhage during TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety evaluation of intra-articular injection of tranexamic acid in total knee arthroplasty operation with temporarily drainage close. Wang, G., Wang, D., Wang, B., et al.[2020]

In a study involving 125 patients undergoing total knee arthroplasty, the use of topical tranexamic acid (TXA) combined with povidone-iodine significantly improved postoperative hemoglobin levels and reduced blood loss compared to a control group that only received povidone-iodine.

The application of TXA did not lead to any significant complications, indicating that it is a safe and effective method to minimize bleeding during and after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding reduction after topical application of tranexamic acid together with Betadine solution in total knee arthroplasty. A randomised controlled study. Carvalho, LH., Frois Temponi, E., Machado Soares, LF., et al.[2018]

A case of cystoid macular edema (CME) developed in a pseudophakic patient after switching from latanoprost to BAK-free travoprost, highlighting a potential risk associated with this medication change.

The patient's CME improved after discontinuing travoprost and using topical prednisolone and anti-inflammatory medications, indicating that while travoprost can control intraocular pressure, it may pose risks for certain patients, particularly those with high-risk eyes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cystoid macular edema in a pseudophakic patient after switching from latanoprost to BAK-free travoprost. Esquenazi, S.[2018]

Topical application of 0.5% nepafenac significantly reduced retinal edema by 65% and inhibited blood-retinal barrier breakdown by 62% in a rabbit model of inflammation, indicating its efficacy in treating retinal conditions.

Nepafenac also nearly completely suppressed PGE2 synthesis (96%), showcasing its strong anti-inflammatory properties compared to other treatments like Voltaren and Acular, which did not show similar effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammation-mediated retinal edema in the rabbit is inhibited by topical nepafenac. Kapin, MA., Yanni, JM., Brady, MT., et al.[2019]

In a study of 20 patients with bullous keratopathy treated with tranexamic acid for 3 to 16 months, all patients experienced a decrease in central corneal thickness and improved visual acuity, indicating the treatment's efficacy.

All patients reported relief from pain, suggesting that tranexamic acid not only improves corneal health but also enhances patient comfort, potentially through mechanisms involving the complement system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bullous keratopathy (Fuchs' endothelial dystrophy) treated systemically with 4-trans-amino-cyclohexano-carboxylic acid. Bramsen, T., Ehlers, N.[2019]

In a study involving 6 eyes of 5 patients, topical nepafenac 0.1% demonstrated a statistically significant improvement in visual acuity after an average of 210 days, with 4 eyes gaining vision and 2 maintaining their vision.

The treatment also led to a significant reduction in foveal thickness, indicating its potential efficacy in addressing diabetic macular edema, which suggests that further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical nepafenac in the treatment of diabetic macular edema. Callanan, D., Williams, P.[2022]

In a study of 59 patients undergoing cataract surgery, the topical nonsteroidal anti-inflammatory drug (nepafenac 0.1%) was found to be significantly more effective than the steroidal anti-inflammatory drug (fluorometholone 0.1%) in preventing cystoid macular edema (CME), with only 14.3% incidence in the nepafenac group compared to 81.5% in the fluorometholone group.

Nepafenac also resulted in a quicker recovery of visual acuity, with 80.0% of patients showing improvement compared to 55.2% in the fluorometholone group, and it caused less disruption to the blood-aqueous barrier, indicating its superior efficacy and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. Miyake, K., Ota, I., Miyake, G., et al.[2022]

Postoperative intravenous tranexamic acid (TXA) significantly reduced total blood loss (TBL) and hidden blood loss (HBL) in patients undergoing total knee arthroplasty (TKA) compared to a placebo, with no significant differences between two dosing regimens of TXA.

The use of TXA did not increase the incidence of venous thromboembolism (VTE) or other complications, indicating it is a safe option for managing blood loss in TKA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Study. Xue, CX., Yao, YF., Lv, H., et al.[2021]

A meta-analysis of six randomized controlled trials found that both intra-articular and intravenous administration of tranexamic acid (TXA) during total knee arthroplasty (TKA) resulted in similar outcomes regarding total blood loss, transfusion requirements, and hemoglobin drop.

Intra-articular TXA application is as effective as intravenous administration in reducing blood loss and transfusion rates without increasing the risk of complications, such as deep vein thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intra-articular versus intravenous application of tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials. Liu, Y., Meng, F., Yang, G., et al.[2022]

In a study of 60 patients undergoing bilateral total knee arthroplasty, intravenous tranexamic acid (TXA) significantly reduced total blood loss and the need for blood transfusions compared to the control group, indicating its efficacy in managing perioperative blood loss.

The use of TXA did not increase the risk of deep vein thrombosis or other thromboembolic events, suggesting it is a safe option for patients undergoing knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A PROSPECTIVE RANDOMIZED SELF-CONTROLLED STUDY ON EFFECT OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS IN TOTAL KNEE ARTHROPLASTY]. Huang, Z., Zhang, W., Li, W., et al.[2018]

In a study of 64 patients undergoing total knee arthroplasty, both intravenous (IV) and topical tranexamic acid (TXA) were found to be equally effective in reducing perioperative blood loss, with no significant differences in blood loss or hemoglobin levels between the two groups.

However, the IV group required more blood transfusions and reported lower post-operative knee pain compared to the topical group, suggesting that while topical TXA is effective, the method of administration may influence patient comfort post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intravenous and topical tranexamic acid in total knee arthroplasty. Wei, W., Dang, S., Duan, D., et al.[2019]

The BAK-free TearClear latanoprost ophthalmic solution (TC-002) demonstrated similar systemic and ocular pharmacokinetics to the BAK-containing reference drug (Xalatan™), indicating it delivers the active ingredient effectively without the preservative.

In a 28-day toxicity study, TC-002 was well tolerated with no abnormal ocular findings, suggesting it is a safer alternative that avoids the risks associated with long-term exposure to preservatives like benzalkonium chloride.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Ocular Toxicity Evaluation of Latanoprost Ophthalmic Solution, 0.005%, with Preservative Level Reduced to Below the Limit of Quantitation. Venkatesh, S., Richardson, M.[2023]

The combined use of pre-operative oral and post-operative intravenous tranexamic acid (TXA) in 25 patients undergoing total knee arthroplasty (TKA) effectively reduced blood loss, with 88% of patients experiencing less than 500 ml of drain output and 72% having a maximum 15% fall in hemoglobin, indicating a successful blood-conserving strategy.

No serious complications such as implant loosening, infection, or thromboembolic events were reported, highlighting the safety of this TXA regimen in TKA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Combining Two Different Routes of TXA Administration an Effective Blood Conserving Strategy for Total Knee Arthroplasty. Dua, M., Bhardwaj, V., Dahiya, M.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11346880/

The Effect of Intravenous Tranexamic Acid on ... Systemic tranexamic acid may reduce postoperative ecchymoses after upper blepharoplasty surgery, reaching significance at the eighth postoperative day.

2. link.springer.com link.springer.com/article/10.1007/s00266-025-05294-w

Evaluating Tranexamic Acid's Role in Upper Eyelid ... Both SC and IV TXA showed significantly better results when compared to the control, (SMD = – 0.39, 95% CI: [– 0.59 to – 0.19], p < 0.0001), and ...

3. researchgate.net researchgate.net/publication/397000826_Evaluating_Tranexamic_Acid's_Role_in_Upper_Eyelid_Blepharoplasty_A_Systematic_Review_and_Meta-Analysis

(PDF) Evaluating Tranexamic Acid's Role in Upper Eyelid ... Conclusion TXA significantly reduces ecchymosis, expedites recovery, and enhances operative time and hemostasis in blepharoplasty. These ...

4. withpower.com withpower.com/trial/phase-4-ecchymosis-6-2024-6df28

Tranexamic Acid for Swollen Eyes A high initial dose of 60 mg/kg intravenous tranexamic acid (IV-TXA) significantly reduced peri-operative blood loss and transfusion rates in 132 patients ...

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

Role of tranexamic acid (TXA) in plastic and reconstructive ... The present study reports the current practices of TXA usage in plastic and reconstructive surgery procedures among members of the American Society of Plastic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080886/

Effect of Subcutaneous Injection of Tranexamic Acid on ... Subcutaneous TXA was safe and reduced periocular ecchymosis and edema compared to contralateral placebo injections in this series of patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06450392

The Effect of Local and Systemic Tranexamic Acid on ... The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.

8. researchgate.net researchgate.net/publication/349040497_The_Effects_of_Intraoperative_Local_Tranexamic_Acid_on_Periorbital_Edema_and_Ecchymosis_in_Septorhinoplasty

The Effects of Intraoperative Local Tranexamic Acid on ... Results: Lower Eyelid Edema values were significantly lower in the TXA(+) group than the TXA(-) group on the third day (P = 0.001). There ...