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Antifibrinolytic Agent
Tranexamic Acid Group for Periorbital Cellulitis
Phase 4
Waitlist Available
Led By Wendy W Lee, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial explores if tranexamic acid can reduce bleeding during eye surgeries, allowing for safer and better results.
Eligible Conditions
- Periorbital Cellulitis
- Bleeding
- Blepharitis
- Blood Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative patient ecchymosis
Secondary outcome measures
Eyelid edema
Intraoperative patient bleeding
Patient-perceived outcomes
+2 moreSide effects data
From 2012 Phase 4 trial • 100 Patients • NCT0074011622%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic Acid GroupExperimental Treatment1 Intervention
Participants undergoing standard of care periorbital procedures will be randomized to receive tranexamic acid with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants undergoing standard of care periorbital procedures will be randomized to receive balanced salt solution with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
2018
Completed Phase 4
~42540
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,682 Total Patients Enrolled
Wendy W Lee, MDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently pregnant.You have a history of blood clots.You have known allergies or sensitivities to the study medication called tranexamic acid.You have had previous surgery on your eyelids or on the same side of your tear duct.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group
- Group 2: Tranexamic Acid Group
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Tranexamic Acid Group been granted permission to sell their product by the FDA?
"Tranexamic Acid Group is a medication already approved for use, so it achieved the highest safety rating of 3."
Answered by AI
Is enrollment currently open for this scientific investigation?
"According to clinicaltrials.gov, this particular research is no longer actively recruiting patients; the initial post date was February 1st 2023 and it has not been updated since December 21 2022. Nevertheless, there are over 350 other trials currently seeking participants."
Answered by AI
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