A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in… (NCT05441592) | Clinical Trial Compass
CompletedPhase 4
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
United States107 participantsStarted 2022-08-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Hematomas
Timeframe: Up to approximately 4 weeks after surgery