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Antifibrinolytic Agent
Tranexamic Acid for Postoperative Complications
Phase < 1
Waitlist Available
Led By Riley McLean, MD
Research Sponsored by Riley McLean
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 30 minutes post initial injection
Awards & highlights
Study Summary
This trial will evaluate whether injecting tranexamic acid (TXA) before Mohs surgery can help reduce bleeding and pain during surgery, and lead to fewer post-operative complications.
Eligible Conditions
- Skin Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day of surgery to 12 weeks post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day of surgery to 12 weeks post-operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative Complications
Secondary outcome measures
Hemostasis
Injection Pain
Side effects data
From 2021 Phase 3 trial • 1226 Patients • NCT047331575%
Vomiting
2%
Dizziness
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Group/Group A_(Tranexamic Acid)
Control Group/Group B_(Placebo)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tranexamic acidExperimental Treatment2 Interventions
The TXA group will receive 2% lidocaine with 1:100,000 epinephrine mixed 50/50 with 50mg/ml TXA (with 50% dilution, this will yield 1% lidocaine with 1:200,000 epi).
Group II: ControlActive Control1 Intervention
The control group will use the routine local anesthetic of buffered 1% lidocaine with 1:200,000 epinephrine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid injection
2021
Completed Phase 4
~3060
Lidocaine Epinephrine
2019
N/A
~170
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Who is running the clinical trial?
Riley McLeanLead Sponsor
Riley McLean, MDPrincipal InvestigatorUniversity of Massachusetts, Worcester
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You are currently taking medication called systemic retinoids.You are allergic to TXA.You have had a blood clot in a deep vein or in your lungs before.
Research Study Groups:
This trial has the following groups:- Group 1: Tranexamic acid
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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