Use of Tranexamic Acid in Reduction Mammoplasty

NCT04947514 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2021-13090
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematoma Postoperative; Venous Thromboembolism

Keywords

breast reduction mammoplasty; hematoma; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Requiring a Blood Transfusion

  Up to 30 days

• Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism

  Up to 30 days

Study Arms (2)

Treatment Side (Right or Left)

OTHER

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

Non-Treatment Side (Right or Left)

OTHER

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)

Interventions

Tranexamic acid DRUG

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

Also known as: Cyklokapron

Treatment Side (Right or Left)

Placebo (topical saline) OTHER

The untreated breast will receive topical saline.

Non-Treatment Side (Right or Left)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study population is patients undergoing breast reduction; typically, cisgender females elect to undergo breast reduction.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over the age of 18
• Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead
• The Plastic Surgery Foundation: collaborator

Study Sites (1)

Montefiore Medical Center Hutchinson Metro Center Campus

The Bronx, New York, 10461, United States

Location

Related Publications (10)

• 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.

  PMID: 28398469 BACKGROUND

• 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.

  PMID: 29794717 BACKGROUND

• 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.

  PMID: 21358317 BACKGROUND

• 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.

  PMID: 21249650 BACKGROUND

• 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.

  PMID: 21559279 BACKGROUND

• 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.

  PMID: 28938364 BACKGROUND

• 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.

  PMID: 32740567 BACKGROUND

• 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.

  PMID: 26349843 BACKGROUND

• 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.

  PMID: 28655514 BACKGROUND

• 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.

  PMID: 28319822 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Hematoma

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Amy Yao
• Organization: Montefiore Medical Center

amyao@montefiore.org

7189204800

Study Officials

• Joseph A Ricci, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patient and the surgical team will be blinded to which breast has received the study drug
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: October 29, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)