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Use of Tranexamic Acid in Reduction Mammoplasty
Phase 4 trial testing Tranexamic acid in Hematoma Postoperative in 98 participants. Completed in 13 July 2022.
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 98 |
| Start date | 29 October 2021 |
| Primary completion | 13 July 2022 |
| Estimated completion | 13 July 2022 |
| Sites | 1 location across United States |
Montefiore Medical Center
18 and older, female only, with Hematoma Postoperative or Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Side (Right or Left) | 2 | |
| Placebo Side (Right or Left) | 1 |
The number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level
| Group | Value | 95% CI |
|---|---|---|
| Treatment Side (Right or Left) | 0 | |
| Placebo Side (Right or Left) | 0 |
Incidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan)
| Group | Value | 95% CI |
|---|---|---|
| Treatment Side (Right or Left) | 0 | |
| Placebo Side (Right or Left) | 0 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04947514.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing