Clinical trial NCT04947514: Use of Tranexamic Acid in Reduction Mammoplasty
Official title: Use of TRanEXamic Acid in Reduction Mammoplasty (TREX-ARM): a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hematoma Postoperative
Venous Thromboembolism
Keywords: breast reduction mammoplasty
hematoma
tranexamic acid
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: The Plastic Surgery Foundation
First posted: 2021-07-01
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each patient undergoing routine bilateral breast reduction randomized to receive the study drug in either the right or left breast
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Breasts With Development of Hematoma
timeFrame: Up to 30 days
Secondary outcomes:
measure: Number of Participants Requiring a Blood Transfusion
timeFrame: Up to 30 days
measure: Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Hutchinson Metro Center Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Joseph A Ricci, MD
role: PRINCIPAL_INVESTIGATOR
References:
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