Use of Tranexamic Acid in Reduction Mammoplasty

Venous Thromboembolism Clinical Trial

— TREX-ARM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947514
• Other study ID #: 2021-13090
• Status: Completed
• Phase: Phase 4
• Start date: October 29, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: March 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematoma
• Hematoma Postoperative
• Thromboembolism
• Venous Thromboembolism

Intervention

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

Other:
• Placebo (topical saline)
The untreated breast will receive topical saline.

Locations

Country	Name	City	State
United States	Montefiore Medical Center Hutchinson Metro Center Campus	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	The Plastic Surgery Foundation

Country where clinical trial is conducted

United States, 

References & Publications (10)

Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878. — View Citation

Brown S, Yao A, Taub PJ. Antifibrinolytic Agents in Plastic Surgery: Current Practices and Future Directions. Plast Reconstr Surg. 2018 Jun;141(6):937e-949e. doi: 10.1097/PRS.0000000000004421. — View Citation

Dadure C, Sauter M, Bringuier S, Bigorre M, Raux O, Rochette A, Canaud N, Capdevila X. Intraoperative tranexamic acid reduces blood transfusion in children undergoing craniosynostosis surgery: a randomized double-blind study. Anesthesiology. 2011 Apr;114(4):856-61. doi: 10.1097/ALN.0b013e318210f9e3. — View Citation

Guerriero C, Cairns J, Perel P, Shakur H, Roberts I; CRASH 2 trial collaborators. Cost-effectiveness analysis of administering tranexamic acid to bleeding trauma patients using evidence from the CRASH-2 trial. PLoS One. 2011 May 3;6(5):e18987. doi: 10.1371/journal.pone.0018987. — View Citation

Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, Ker K. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD001886. doi: 10.1002/14651858.CD001886.pub3. — View Citation

Kaoutzanis C, Winocour J, Gupta V, Ganesh Kumar N, Sarosiek K, Wormer B, Tokin C, Grotting JC, Higdon KK. Incidence and Risk Factors for Major Hematomas in Aesthetic Surgery: Analysis of 129,007 Patients. Aesthet Surg J. 2017 Oct 16;37(10):1175-1185. doi: 10.1093/asj/sjx062. — View Citation

Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926. — View Citation

Rubio GA, Zoghbi Y, Karcutskie CA, Thaller SR. Incidence and risk factors for venous thromboembolism in bilateral breast reduction surgery: An analysis of the National Surgical Quality Improvement Program. J Plast Reconstr Aesthet Surg. 2017 Nov;70(11):1514-1519. doi: 10.1016/j.bjps.2017.05.050. Epub 2017 Jun 2. — View Citation

Weissler JM, Banuelos J, Jacobson SR, Manrique OJ, Nguyen MT, Harless CA, Tran NV, Martinez-Jorge J. Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events. Plast Reconstr Surg. 2020 Aug;146(2):238-245. doi: 10.1097/PRS.0000000000006967. — View Citation

Xie J, Hu Q, Huang Q, Ma J, Lei Y, Pei F. Comparison of intravenous versus topical tranexamic acid in primary total hip and knee arthroplasty: An updated meta-analysis. Thromb Res. 2017 May;153:28-36. doi: 10.1016/j.thromres.2017.03.009. Epub 2017 Mar 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 30 days
Secondary	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
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)	Up to 30 days