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    Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol.

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    Author
    Pellegrini, Vincent D
    Eikelboom, John William
    Evarts, C McCollister
    Franklin, Patricia D
    Garvin, Kevin L
    Goldhaber, Samuel Z
    Iorio, Richard
    Lambourne, Carol Ann
    Magaziner, Jay
    Magder, Laurence
    Date
    2022-03-08
    Journal
    BMJ Open
    Publisher
    BMJ Publishing Group
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1136/bmjopen-2021-060000
    Abstract
    Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7-2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board.
    Rights/Terms
    © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
    Keyword
    adult orthopaedics
    anaesthesia in orthopaedics
    anticoagulation
    hip
    knee
    thromboembolism
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/18205
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2021-060000
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