Topical Tranexamic Acid for Bilateral Breast Reduction Surgery

NCT04918576 | Unknown Phase 3

• 1 other identifier: 13103
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

Brief Summary

Hematoma is a common complication of bilateral breast reduction (BBR) surgery. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events. In this randomized control trial (RCT) evaluation TXA use in BBR, for which one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in BBR reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

Conditions

Hematoma Postoperative; Tranexamic Acid

Keywords

Breast Reduction

Outcome Measures

Primary Outcomes (2)

• Hematoma

  Incidence rate of hematoma

  2 weeks

• Seroma

  Incidence rate of seroma

  2 weeks

Secondary Outcomes (5)

• Drain output

  24 hours

• Days with drains

  2 weeks

• Reoperation rate

  2 weeks

• Reintervention rate

  2 weeks

• Imaging findings

  2 weeks

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline

Drug: Tranexamic acid

Normal Saline

PLACEBO COMPARATOR

40 mL topical of 0.9% normal saline

Drug: Normal Saline

Interventions

Tranexamic acid DRUG

3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline

Also known as: TXA

Tranexamic Acid

Normal Saline DRUG

40 mL topical of 0.9% normal saline

Also known as: NS

Normal Saline

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 18 years or older;
• Are undergoing bilateral breast reduction at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

You may not qualify if:

• Taking therapeutic anticoagulation;
• Taking antiplatelet drugs;
• Pregnant or breast feeding;
• Allergic to TXA;
• Cannot provide informed consent;
• Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (3)

St. Joseph's Healthcare, King Campus

Hamilton, Ontario, L8G 5E4, Canada

Location

St. Joseph's Healthcare, Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital, Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (10)

• Derby BM, Grotting JC, Redden DT. Vertical Sculpted Pillar Reduction Mammaplasty in 317 Patients: Technique, Complications, and BREAST-Q Outcomes. Aesthet Surg J. 2016 Apr;36(4):417-30. doi: 10.1093/asj/sjv217. Epub 2016 Feb 23.

  PMID: 26906351 BACKGROUND

• DeFazio MV, Fan KL, Avashia YJ, Tashiro J, Ovadia S, Husain T, Camison L, Panthaki ZJ, Salgado CJ, Thaller SR. Inferior pedicle breast reduction: a retrospective review of technical modifications influencing patient safety, operative efficiency, and postoperative outcomes. Am J Surg. 2012 Nov;204(5):e7-14. doi: 10.1016/j.amjsurg.2012.07.015.

  PMID: 23140832 BACKGROUND

• Bauermeister AJ, Gill K, Zuriarrain A, Earle SA, Newman MI. "Reduction mammaplasty with superomedial pedicle technique: A literature review and retrospective analysis of 938 consecutive breast reductions". J Plast Reconstr Aesthet Surg. 2019 Mar;72(3):410-418. doi: 10.1016/j.bjps.2018.12.004. Epub 2018 Dec 14.

  PMID: 30579911 BACKGROUND

• Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.

  PMID: 22611164 BACKGROUND

• Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.

  PMID: 21048170 BACKGROUND

• De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.

  PMID: 10694619 BACKGROUND

• Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.

  PMID: 22202494 BACKGROUND

• Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.

  PMID: 25471907 BACKGROUND

• Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.

  PMID: 23541868 BACKGROUND

• Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.

  PMID: 25450009 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christopher Coroneos, MD, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaeesh Sardiwalla, MD

CONTACT

90505221155; yaeesh.sardiwalla@medportal.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be randomized on the REDCap system. Their assignment will be made available to research team member, which will be preparing syringes with either TXA or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo). Intervention: Topical application of 3 grams of tranexamic acid (30 mL of 100mg/mL) diluted in 10 mL of normal saline in the breast. Placebo: Topical application of 40 mL of 0.9% normal saline to the breast.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 9, 2021
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)