CTOT-18: A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study

    Project: Research project

    Project Details

    Description

    This study is a multicenter, non-randomized, retrospective, chart review study to collect long term (4 years post-transplant +/- 6 months) clinical outcome data on subjects previously enrolled in the CTOT-05 study (STU896). The CTOT-05 study enrolled and transplanted 200 subjects from July 2007 to June 2010. Twenty subjects withdrew consent, were lost to follow up, or died over the study period, and will not be included in the CTOT-18 study. This study will include up to 180 subjects. This study will be completed no later than January 2015. Each center will complete a retrospective chart review for the selected clinical variables identified in the Schedule of Events (Appendix 1), and enter the data in the Statistical and Clinical Coordinating Center (SACCC) electronic data capture system.
    StatusFinished
    Effective start/end date8/1/1412/31/15

    Funding

    • Icahn School of Medicine at Mount Sinai (0255-1358-4424//U01AI063594)
    • National Institute of Allergy and Infectious Diseases (0255-1358-4424//U01AI063594)

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