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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT05441592
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05441592
Study Brief:
Protocol Section:
NCT05441592