Clinical trial NCT04918589: Tranexamic Acid for Alloplastic Breast Reconstruction
Official title: Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hematoma Postoperative
Breast Cancer
Tranexamic Acid
Keywords: Alloplastic Breast Reconstruction
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.

If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed.

One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).

The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hematoma
timeFrame: 2 weeks
measure: Seroma
timeFrame: 2 weeks
Secondary outcomes:
measure: Drain output
timeFrame: 24 hours
measure: Days with drains
timeFrame: 2 weeks
measure: Reoperation rate
timeFrame: 2 weeks
measure: Reintervention rate
timeFrame: 2 weeks
measure: Imaging findings
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, King Campus
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, Charlton Campus
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital, Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Ronen Avram, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Megson M. Traumatic subcutaneous haematoma causing skin necrosis. BMJ Case Rep. 2011 Jul 20;2011:bcr0520114273. doi: 10.1136/bcr.05.2011.4273.
citation: 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.