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NCT04947514 · ClinicalTrials.gov registry record · Phase 4
Use of Tranexamic Acid in Reduction Mammoplasty
A Phase 4 study of Venous Thromboembolism and Hematoma Postoperative, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT04947514: Completed Phase 4 study of Venous Thromboembolism and Hematoma Postoperative, sponsored by Montefiore Medical Center.
NCT04947514 is a Phase 4 study of Venous Thromboembolism and Hematoma Postoperative that has completed, run by Montefiore Medical Center. The registered enrollment target is 98 participants, below the 6,294-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04947514, a Phase 4 study of Venous Thromboembolism and Hematoma Postoperative, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.
Conditions Studied
Interventions
- DRUG Tranexamic acid
- OTHER Placebo (topical saline)
Study Locations (1)
New York
- Montefiore Medical Center Hutchinson Metro Center Campus - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2022-07-13 |
| Phase | Phase 4 |
What the finished NCT04947514 record still lists
NCT04947514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 6,294-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (98% lower).
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.
NCT04947514 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT04947514?
The interventions under investigation include: Tranexamic acid (DRUG), Placebo (topical saline) (OTHER).
Who is sponsoring clinical trial NCT04947514?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04947514's enrollment target sits among peer trials
98 37th of 47 higher than 11 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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