Enrollment rate was slower than anticipated.

This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision 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.

The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.

Inclusion Criteria:

1. Patients older than 18 years old
2. Patients younger than 90 years old
3. Patients undergoing scheduled revision total shoulder arthroplasty
4. Patients who consent to be randomized

Exclusion Criteria:

1. Patients younger than 18

2. Patients older than 90 years old

3. Patients who are pregnant or breast-feeding women

4. Patients who are allergic to tranexamic acid

5. Patients with proximal humerus fracture or fracture sequelae

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

7. Patients who have acquired disturbances of color vision

8. 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]

9. Patients who refuse blood products

10. Patients undergoing hormone replacement therapy

11. Patients with diagnosed or self-reported cognitive dysfunction;

12. Patients who are unable to understand or follow instructions;

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

14. Patients with BMI over 50

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

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) 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.

The investigator who proposed to use the data upon reasonable request. Requests should be directed to Uchenna.Umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

2 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.