Tranexamic Acid for Swollen Eyes

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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Tranexamic Acid for swollen eyes?

While there is no direct evidence for using Tranexamic Acid for swollen eyes, studies show it effectively reduces blood loss and inflammation in knee surgery, suggesting it might help with swelling due to its anti-inflammatory properties. ^{1 2 3 4 5}

Is tranexamic acid safe for humans?

Tranexamic acid, known by various names like Cyklokapron and Lysteda, is generally considered safe for humans and has been used for different conditions, including heavy menstrual bleeding and to reduce bleeding during surgery. However, like any medication, it can have side effects, so it's important to discuss its use with a healthcare provider. ^{6 7 8 9 10}

How is the drug tranexamic acid unique for treating swollen eyes?

Tranexamic acid is unique for treating swollen eyes because it is an antifibrinolytic drug, which means it helps prevent the breakdown of blood clots, and it has shown effectiveness in reducing corneal thickness and improving visual acuity in conditions like bullous keratopathy, which may suggest potential benefits for eye swelling. ^{3 11 12 13 14}

What is the purpose of this trial?

Tranexamic acid is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.

Research Team

Anne Barmettler

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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 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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[A PROSPECTIVE RANDOMIZED SELF-CONTROLLED STUDY ON EFFECT OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS IN TOTAL KNEE ARTHROPLASTY]. [2018]

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

Comparison of intravenous and topical tranexamic acid in total knee arthroplasty. [2019]

3. Germany 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. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Is Combining Two Different Routes of TXA Administration an Effective Blood Conserving Strategy for Total Knee Arthroplasty. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Study. [2021]

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

Inflammation-mediated retinal edema in the rabbit is inhibited by topical nepafenac. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Topical nepafenac in the treatment of diabetic macular edema. [2022]

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

Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. [2022]

9. United States 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. [2023]

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

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

11. United States 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. [2020]

12. Denmark pubmed.ncbi.nlm.nih.gov

Bullous keratopathy (Fuchs' endothelial dystrophy) treated systemically with 4-trans-amino-cyclohexano-carboxylic acid. [2019]

13. Poland 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. [2022]

14. France 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. [2018]