TXA in Revision Total Shoulder Arthroplasty

NYU Langone Health

Status and phase

Terminated

Phase 4

Conditions

Arthropathy Shoulder

Treatments

Drug: Tranexamic acid (TXA) injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04650698

20-01617

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients older than 18 years old
Patients younger than 90 years old
Patients undergoing scheduled revision total shoulder arthroplasty
Patients who consent to be randomized

Exclusion criteria

Patients younger than 18
Patients older than 90 years old
Patients who are pregnant or breast-feeding women
Patients who are allergic to tranexamic acid
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.