Tranexamic Acid for Alloplastic Breast Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial

Conditions
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Hematoma Postoperative, Breast Cancer, Tranexamic Acid

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline | Drug: Tranexamic acid<br>* 3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline<br>* Other names: TXA;|
| Placebo Comparator: Normal Saline<br>40 mL topical of 0.9% normal saline | Drug: Normal Saline<br>* 40 mL topical of 0.9% normal saline<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma | Incidence rate of hematoma | 2 weeks | 
| Seroma | Incidence rate of seroma | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain output | Total drain output (mL) at 24 hours | 24 hours | 
| Days with drains | Total number of days drains in situ with standard discharge criteria | 2 weeks | 
| Reoperation rate | Number of repeat operations required for patient related to complication | 2 weeks | 
| Reintervention rate | Rate of subsequent interventions including aspiration, repeat drain insertion or other | 2 weeks | 
| Imaging findings | Ultrasound findings of hematoma or seroma, if applicable | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alloplastic Breast Reconstruction