TXA in Anticoagulated Patients Study

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Tranexamic Acid

Criteria

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.