TXA in Anticoagulated Patients Study

  • STATUS
    Recruiting
  • End date
    Jan 20, 2025
  • participants needed
    82
  • sponsor
    NYU Langone Health
Updated on 4 October 2022

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.

Details
Condition Total Shoulder Athroplasty
Treatment Tranexamic acid injection
Clinical Study IdentifierNCT04560010
SponsorNYU Langone Health
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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