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Use of Tranexamic Acid in Reduction Mammoplasty

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04947514
Acronym
TREX-ARM
Enrollment
98
Registered
2021-07-01
Start date
2021-10-29
Completion date
2022-07-13
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematoma Postoperative, Venous Thromboembolism

Keywords

breast reduction mammoplasty, hematoma, tranexamic acid

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.

Interventions

DRUGTranexamic acid

Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.

OTHERPlacebo (topical saline)

The untreated breast will receive topical saline.

Sponsors

The Plastic Surgery Foundation
CollaboratorOTHER
Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Masking description

The patient and the surgical team will be blinded to which breast has received the study drug

Intervention model description

Each patient undergoing routine bilateral breast reduction randomized to receive the study drug in either the right or left breast

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Breasts With Development of HematomaUp to 30 daysThe number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.

Secondary

MeasureTime frameDescription
Number of Participants Requiring a Blood TransfusionUp to 30 daysThe number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level
Number of Participants With Deep Vein Thrombosis/Venous ThromboembolismUp to 30 daysIncidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan)

Countries

United States

Participant flow

Pre-assignment details

Patients undergoing bilateral reduction mammoplasty were enrolled in this study. One breast was randomized to receive the treatment, the other received a placebo; therefore, there were 98 patients enrolled and 196 treated breasts.

Participants by arm

ArmCount
Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline)
Each patient undergoing routine bilateral breast reduction was 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 received topical saline. Treatment: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions. OR Placebo (topical saline): The untreated breast will receive topical saline.
98
Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline)
Each patient undergoing routine bilateral breast reduction was 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 received topical saline. Treatment: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions. OR Placebo (topical saline): The untreated breast will receive topical saline.
196
Total294

Baseline characteristics

CharacteristicTreatment Side (Tranexamic Acid) or Placebo Side (Topical Saline)
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
98 Participants
Age, Continuous34.14 years
STANDARD_DEVIATION 12.87
Ethnicity (NIH/OMB)
Hispanic or Latino
49 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
18 Participants
Race (NIH/OMB)
More than one race
57 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants
Race (NIH/OMB)
White
3 Participants
Region of Enrollment
United States
98 participants
Sex: Female, Male
Female
98 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 980 / 98
other
Total, other adverse events
0 / 980 / 98
serious
Total, serious adverse events
0 / 980 / 98

Outcome results

Primary

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.

Time frame: Up to 30 days

Population: One of the two breasts was randomized to receive the study drug, the other breast was randomized to receive saline. As all participants had a bilateral operation performed, there were 196 analyzed units for 98 participants.

ArmMeasureValue (NUMBER)
Treatment Side (Right or Left)Number of Breasts With Development of Hematoma2 breasts
Placebo Side (Right or Left)Number of Breasts With Development of Hematoma1 breasts
Secondary

Number of Participants Requiring a Blood Transfusion

The number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level

Time frame: Up to 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment Side (Right or Left)Number of Participants Requiring a Blood Transfusion0 Participants
Placebo Side (Right or Left)Number of Participants Requiring a Blood Transfusion0 Participants
Secondary

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)

Time frame: Up to 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment Side (Right or Left)Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism0 Participants
Placebo Side (Right or Left)Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026