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Antifibrinolytic Agent
Non-Treatment Side (Right or Left) for Deep Vein Thrombosis (TREX-ARM Trial)
Phase 4
Waitlist Available
Led By Joseph A Ricci, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Being over the age of 18
Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
TREX-ARM Trial Summary
This study is evaluating whether tranexamic acid can reduce the risk of hematoma after breast reduction surgery.
Eligible Conditions
- Deep Vein Thrombosis
- Hematoma
TREX-ARM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTREX-ARM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Breasts With Development of Hematoma
Secondary outcome measures
Number of Participants Requiring a Blood Transfusion
Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism
TREX-ARM Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment Side (Right or Left)Experimental Treatment1 Intervention
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
Group II: Non-Treatment Side (Right or Left)Experimental Treatment1 Intervention
Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.
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?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,098 Total Patients Enrolled
The Plastic Surgery FoundationOTHER
8 Previous Clinical Trials
1,049 Total Patients Enrolled
Joseph A Ricci, MDPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine
Frequently Asked Questions
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