A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

Study Overview
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Brief Summary
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This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.

Official Title
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A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

Conditions
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Hematoma Postoperative

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Other: No additional irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable. For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable Exclusion Criteria: Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion Current use of systemic anticoagulation Hypersensitivity to tranexamic acid Concomitant use of combined hormonal contraceptives Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid History of acquired defective color vision History of subarachnoid hemorrhage Pregnancy History of renal impairment or serum Creatinine >1.5 milligrams per deciliter (mg/dL)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irrigation that contains tranexamic acid (TXA)<br> | Drug: Tranexamic acid injection<br>* The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.<br>|
| Other: No additional irrigation usual care<br> | Other: No additional irrigation<br>* There will be no additional irrigation after the standard surgical procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA |  | Up to approximately 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing a major thromboembolic event related to the study drug | Major thromboembolic events include, but are not limited to: deep vein thrombosis, pulmonary embolism, stroke | Up to approximately 4 weeks after surgery | 
| Number of participants experiencing major complications other than hematoma | Major complications include, but are not limited to: infection, seroma, hypersensitivity reaction to TXA, renal impairment | Up to approximately 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast reduction, Gender-affirming mastectomy, Tranexamic Acid