CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 98 enrolled
Drug / intervention
Tranexamic acid +1 moredrug
Likely dose
Tranexamic acid 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04947514
NCT04947514Phase 4Completed

Use of TRanEXamic Acid in Reduction Mammoplasty (TREX-ARM): a Double-blinded Randomized Controlled Trial

Montefiore Medical Center·interventional·Posted Jul 1, 2021·Updated Apr 10, 2023

In Brief

A Phase 4 clinical trial evaluating Tranexamic acid and Placebo (topical saline) for Hematoma Postoperative and Venous Thromboembolism. Completed, enrolled 98 participants across 1 site.

Detailed Summary

Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes. Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJul 1, 2021
Enrollment StartOct 29, 2021
Primary CompletionJul 13, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.0 years ago

Interventions

Tranexamic aciddrug

Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.

Placebo (topical saline)other

The untreated breast will receive topical saline.