This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
NYU Langone Health
New York, New York, United States
Calculated Total Blood Loss
"The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗\_loss/〖Hb〗\_i"
Time frame: Baseline to 24 hours post op
Total Surgical Drain Output
Surgical drain output will be recorded by floor nurse every 8 hours in EPIC. Data will be recorded up to 24 hours post-op if needed.
Time frame: Up to 24 hours post-op
Number of Participants With Presence of Hematoma
Surgeon will assess for presence of hematoma at the 2-week follow up visit.
Time frame: 2 weeks post-op
Number of Participants Who Needed a Post-op Blood Transfusion
Time frame: Up to 24 hours post-op
Average Operative Time
Time frame: During operation, up to 4 hours
Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)
Time frame: Up until 30 days after last day of study participation, an average of 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.