Tranexamic Acid for Alloplastic Breast Reconstruction

NCT04918589 | Unknown Phase 3

• 1 other identifier: 13104
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

Brief Summary

Hematoma is a common complication of alloplastic breast reconstruction. 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) assessing TXA use in alloplastic breast reconstruction, 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 alloplastic breast reconstruction 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; Breast Cancer; Tranexamic Acid

Keywords

Alloplastic Breast Reconstruction

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 (30 mL 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 (30 mL 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 one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy 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;
• Alloplastic reconstruction is not performed immediately after mastectomy;
• 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 (12)

• 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

• Knight H, Banks J, Muchmore J, Ives C, Green M. Examining the use of intraoperative tranexamic acid in oncoplastic breast surgery. Breast J. 2019 Sep;25(5):1047-1049. doi: 10.1111/tbj.13409. Epub 2019 Jun 11. No abstract available.

  PMID: 31187540 BACKGROUND

• Pinsolle V, Grinfeder C, Mathoulin-Pelissier S, Faucher A. Complications analysis of 266 immediate breast reconstructions. J Plast Reconstr Aesthet Surg. 2006;59(10):1017-24. doi: 10.1016/j.bjps.2006.03.057. Epub 2006 Jun 5.

  PMID: 16996422 BACKGROUND

• Nelson JA, Fischer JP, Grover R, Cleveland E, Erdmann-Sager J, Serletti JM, Wu LC. The impact of anemia on microsurgical breast reconstruction complications and outcomes. Microsurgery. 2014 May;34(4):261-70. doi: 10.1002/micr.22202. Epub 2013 Nov 4.

  PMID: 24436188 BACKGROUND

• Megson M. Traumatic subcutaneous haematoma causing skin necrosis. BMJ Case Rep. 2011 Jul 20;2011:bcr0520114273. doi: 10.1136/bcr.05.2011.4273.

  PMID: 22689664 BACKGROUND

• Rogoff H, Marquez JE, Ghosh K, Jou C, McAuliffe P, Rathi S, Monroig K, Medrano C, Marmor WA, Ferrier A, Kapadia K, Klein G, Huston TL, Ganz J, Dagum AB, Khan S, Bui D. Clinical Outcomes After Hematoma Development: A Study of 627 Tissue Expander Breast Reconstructions. Ann Plast Surg. 2020 Jul;85(S1 Suppl 1):S63-S67. doi: 10.1097/SAP.0000000000002343.

  PMID: 32243320 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ronen Avram, MD, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh Huynh, MD

CONTACT

9055221155; minh.huynh@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 100 mg/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)