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COMPLETED Phase 4

Use of Tranexamic Acid in Reduction Mammoplasty

NCT04947514 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Tranexamic acid
  • OTHER Placebo (topical saline)

Study Locations (1)

New York

  • Montefiore Medical Center Hutchinson Metro Center Campus — The Bronx

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2021-10-29
Est. Completion 2022-07-13
Phase Phase 4

Sponsor

Montefiore Medical Center

280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04947514

The ClinicalTrials.gov registry entry for NCT04947514 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Venous Thromboembolism appearing as the primary indexed condition, and to 2 interventions — of which Tranexamic acid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04947514 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04947514 about?

NCT04947514 is a clinical study titled "Use of Tranexamic Acid in Reduction Mammoplasty". 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, an...

What is the current status of trial NCT04947514?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 98 participants. The study started on 2021-10-29. Estimated completion is 2022-07-13.

What conditions does trial NCT04947514 study?

This clinical trial studies the following conditions: Venous Thromboembolism, Hematoma Postoperative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04947514?

The interventions under investigation include: Tranexamic acid (DRUG), Placebo (topical saline) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04947514?

This trial is sponsored by Montefiore Medical Center, which has 280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04947514 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial