Use of Tranexamic Acid in Reduction Mammoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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Prevention of perioperative blood loss is a chief consideration in plastic surgery. Breast reduction mammoplasty (BRM) is one of the most commonly performed procedures in plastic surgery, with over 100,000 performed in the United States in 2019 alone. Postoperative hematomas are among the most frequent complications following BRM, with a reported incidence between 0.3-7% in the literature. Many of these hematomas require blood transfusions and/or urgent surgical evacuation to avoid the consequent wound healing issues arising from increased tension on the closure. Tranexamic acid (TXA) has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. TXA is an antifibrinolytic agent that acts by stabilizing clot formation, and may be administered intravenously, orally, or topically. Topical administration of TXA has been shown to be as efficacious as intravenous dosing, though with substantially less systemic absorption. Multiple randomized controlled trials have demonstrated that TXA significantly reduces intraoperative bleeding and need for subsequent blood transfusion, without an increased risk of thromboembolic events. Moreover, TXA has been shown to be cost-effective in the surgical setting, not only by reducing direct hospital costs (drug and blood products), but also by decreasing subsequent costs by shortening length of stay and lowering the incidence of complications. However, the use of TXA in plastic surgery has not been well described. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of TXA in patients undergoing BRM. The primary outcome variable will be the rate of hematoma development. The secondary outcome variables will be the incidence of blood transfusion and the incidence of thromboembolic events. The investigators will also collect a broad range of preoperative variables, surgical details, and other characteristics that may impact the perioperative bleeding risk. All patients eligible for reduction mammoplasty between July 1, 2021 and June 30, 2022 will be included in this study. The investigators hypothesize that use of TXA will decrease total perioperative blood loss, hematoma formation, and transfusion rates following reduction mammoplasty without increasing the incidence of thromboembolic events. Better understanding of the effect of TXA in reduction mammoplasty may be of great utility to the field of plastic surgery.

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

Conditions
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Hematoma Postoperative, Venous Thromboembolism

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: Placebo (topical saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over the age of 18 Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York Exclusion Criteria: Oncologic breast reduction Unilateral breast reduction History of thromboembolic disease History of bleeding diatheses History of stroke History of seizure disorder Currently pregnant Severe comorbidity (defined as American Society of Anesthesiologists (ASA) fitness grade IV or above)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each patient undergoing routine bilateral breast reduction randomized to receive the study drug in either the right or left breast
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment Side (Right or Left)<br>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. | Drug: Tranexamic acid<br>* Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.<br>* Other names: Cyklokapron;|
| Other: Non-Treatment Side (Right or Left)<br>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. | Other: Placebo (topical saline)<br>* The untreated breast will receive topical saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Breasts With Development of Hematoma | The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined. | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring a Blood Transfusion | The number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level | Up to 30 days | 
| Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism | Incidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan) | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reduction mammoplasty, hematoma, tranexamic acid