Local Injection of Tranexamic Acid May Reduce Bleeding, Injection Pain, and Other Post-op Complications During Mohs Micrographic Surgery

H00019337

The purpose of this study is to evaluate the use of locally injected tranexamic acid (TXA) under the skin during Mohs micrographic surgery for removal of skin cancers in patients on anticoagulation. TXA may be helpful in reducing bleeding and pain during surgery, and may also lead to fewer post-operative complications following surgery such as graft loss, specifically in patients on blood-thinners.

2021-06-16

2023-08-01

2023-12-01

Early phase I

200

Inclusion Criteria: * Must be on systemic anticoagulation therapy (indirect or direct anticoagulants or anti-platelet agents) * Must be scheduled for Mohs surgery at the University of Massachusetts Department of Dermatology Exclusion Criteria: * History of hypercoaguable disorder (e.g. Factor V Leiden Deficiency) * History of deep vein thrombosis or pulmonary embolism * Systolic blood pressure greater than 200 on day of surgery * Known allergy to TXA * Currently taking systemic retinoids * Unable to consent * Pregnant women * Prisoners

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Once a participant has provided informed consent to participate in the study, he/she will be randomly assigned to either the TXA experimental group or the control group. A randomized list will be created prior to the start of the study with the help of a biostatistician. The provider will be aware of which study arm the participant is in, however the participant will be blinded.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The surgeon performing the Mohs surgery will be aware of which group the participant is in. The participant will be masked.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-06-22