Clinical trial NCT04918576: Topical Tranexamic Acid for Bilateral Breast Reduction Surgery
Official title: A Randomized Control Trial Evaluating the Use of Topical Tranexamic Acid in Bilateral Breast Reduction Surgery to Prevent Bleeding Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hematoma Postoperative
Tranexamic Acid
Keywords: Breast Reduction
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 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.
Primary purpose: TREATMENT

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.

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 bilateral breast reduction (BBR). 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 reduction. 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 bilateral breast reduction 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;
* 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: Christopher Coroneos, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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