Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02615366
Eligibility Criteria:
Inclusion Criteria:
* Patient requires and is a candidate for any of the following surgical procedures: Reduction mammaplasty, mastectomy with and without immediate tissue expander and implant-based reconstruction, oncoplastic breast surgery.
* Patient has OHIP approval for surgery.
* Patient is willing and able (ie. English/French-speaking and cognitively intact) to read and complete patient diaries, demographic forms, and consent forms and be followed-up for a 2 weeks, 6 weeks, 12 weeks postoperatively.
* Patient is 18 years of age or older
Exclusion Criteria:
* Patient is allergic to tranexamic acid
* Patient has a history or present laboratory signs of bleeding disorders (abnormal platelet counts, prothrombin time, partial thromboplastin time, etc.), coagulopathy or thromboembolic events
* Patient is being treated for a stroke
* Patient has a history of bleeding in the brain
* Patient has an acquired disturbance of colour vision
* Patient has a history of myocardial infarction within the last year
* Patient is presenting with unstable angina or severe coronary disease
* Patient has reduced renal function with plasma creatinine levels above 250 umol/L ix.
* Patient has haematuria
* Patient is currently using a form of birth control that contains estrogen and a progestin
* Patient has irregular menstrual bleeding of unknown cause
* Patient is unable to complete required forms due to language and cognitive problems
* Patient is not capable of communicating in, and understanding, English or French
* Patient is currently pregnant and is expected to be pregnant during any point of the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02615366
Study Brief:
Protocol Section:
NCT02615366