TXA in Revision Total Shoulder Arthroplasty

• Status: Recruiting
• Trial end date: 2024-11-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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.