Status:
UNKNOWN
Tranexamic Acid for Alloplastic Breast Reconstruction
Lead Sponsor:
McMaster University
Conditions:
Hematoma Postoperative
Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
PHASE3
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. Pr...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04918589
Start Date
August 1 2022
End Date
August 1 2024
Last Update
April 6 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Healthcare, King Campus
Hamilton, Ontario, Canada, L8G 5E4
2
St. Joseph's Healthcare, Charlton Campus
Hamilton, Ontario, Canada, L8N 4A6
3
Juravinski Hospital, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3