TXA in Anticoagulated Patients Study

NYU Langone Health

Status and phase

Terminated

Phase 4

Conditions

Total Shoulder Athroplasty

Treatments

Drug: Tranexamic Acid Injection (TXA)

Study type

Interventional

Funder types

Other

Identifiers

NCT04560010

20-00803

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.