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.
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.
Brief Title
Use of Tranexamic Acid in Reduction Mammoplasty
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Hematoma Postoperative
Venous Thromboembolism
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)
* 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)
Inclusion 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
* Being over the age of 18
* Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York
Gender
Female
Gender Based
false
Keywords
breast reduction mammoplasty
hematoma
tranexamic acid
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04947514
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-13090
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Use of TRanEXamic Acid in Reduction Mammoplasty (TREX-ARM): a Double-blinded Randomized Controlled Trial
Primary Outcomes
Outcome Description
The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.
Outcome Measure
Number of Breasts With Development of Hematoma
Outcome Time Frame
Up to 30 days
Secondary Outcomes
Outcome Description
The number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level
Outcome Time Frame
Up to 30 days
Outcome Measure
Number of Participants Requiring a Blood Transfusion
Outcome Description
Incidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan)
Outcome Time Frame
Up to 30 days
Outcome Measure
Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Ricci
Investigator Email
josricci@montefiore.org
Investigator Phone
917-801-5577
Categories Mesh Debug
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood Disorders --- HEMORRHAGE
MeSH Terms
VENOUS THROMBOEMBOLISM
HEMATOMA
THROMBOEMBOLISM
EMBOLISM AND THROMBOSIS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
HEMORRHAGE
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
TRANEXAMIC ACID
COUNTERFEIT DRUGS
SALINE SOLUTION
CYCLOHEXANECARBOXYLIC ACIDS
ACIDS, CARBOCYCLIC
CARBOXYLIC ACIDS
ORGANIC CHEMICALS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS
CRYSTALLOID SOLUTIONS
ISOTONIC SOLUTIONS
SOLUTIONS