Enrollment rate was slower than anticipated

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.

Inclusion Criteria

• Patients older than 18 years old

• Patients undergoing scheduled primary anatomic total shoulder arthroplasty

• Patients undergoing scheduled primary reverse total shoulder arthroplasty

• Patients who consent to be randomized

• Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery:

  • Coumadin (Warfarin)
  • Heparin
  • Low molecular weight heparin
  • Factor Xa inhibitors
  • Apixaban (Eliquis)
  • Rivarixaban (Xatelto)
  • Edoxaban (Savaysa)
  • Dabigatran (Pradaxa)
  • Clopidogrel (Plavix)
  • Prasugrel (Effient)
  • Ticagrelor (Brilinta)

Exclusion Criteria

• Patients younger than 18

• Patients who are pregnant* or breast-feeding women

• Patients who are allergic to tranexamic acid

• Patients scheduled for revision total shoulder arthroplasty

• Patients with proximal humerus fracture or fracture sequelae

• Patients who use estrogen containing medications (i.e. oral contraceptive pills)

• Patients who have acquired disturbances of color vision

• Patients with a history of any of the following diagnosis: '

  • Subarachnoid hemorrhage
  • Active intravascular clotting
  • Severe pulmonary disease (FEV <50% normal)
  • Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
  • (Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
  • Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]

• Patients who refuse blood products

• Patients undergoing hormone replacement therapy

• Patients with diagnosed or self-reported cognitive dysfunction;

• Patients who are unable to understand or follow instructions;

• Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;

• Patients with BMI over 50

• Any patient that the investigators feel cannot comply with all study related procedures.

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

9 months and ending 36 months following article publication

Requests may be directed to the PI.

Other (Not Including Serious) Adverse Events were collected for a period of 2 weeks. Serious Adverse Events and All-Cause Mortality was assessed up until 30 days after last day of study participation, up to 6 weeks

Neither the anesthesiologist or surgeon will be blinded to the patient's group assignment, as they will be the one performing the treatment. All other stakeholders (patient, other caregivers, and research staff collecting the data) will be blinded to the patient's group assignment.