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A Demming Approach to Recruiting: The National Institute of Neurological Diseases and Stroke (NINDS) t-PA Stroke Trial Experience

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Thrombolytic Therapy in Acute Ischemic Stroke II

Abstract

The NINDS t-PA Stroke Trials are two Phase IIB, randomized, double-blind trials comparing recombinant tissue plasminogen activator (t-PA) to placebo. The trials are being carried out by 8 clinical centers and 40 participating hospitals. The primary alternative hypotheses for each trial are that:

  1. 1.

    There is a difference between the t-PA and placebo groups enrolled within 90 min of onset in the proportion showing significant early improvement; and

  2. 2.

    There is a difference between the t-PA and placebo groups enrolled between 91 and 180 min of stroke onset in the proportion showing significant early improvement.

Division of Biostatistics and Research Epidemiology, Henry Ford Health Sciences Center, South-field, OH, USA for The NINDS t-PA Stroke Trial Investigators. Please see Appendix.

Presented by K. M. A. Welch, William T. Gossett, Chair, Department of Neurology, Henry Ford Health Sciences Center, Detroit, MI, USA

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© 1993 Springer-Verlag Berlin Heidelberg

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Tilley, B.C. (1993). A Demming Approach to Recruiting: The National Institute of Neurological Diseases and Stroke (NINDS) t-PA Stroke Trial Experience. In: del Zoppo, G.J., Mori, E., Hacke, W. (eds) Thrombolytic Therapy in Acute Ischemic Stroke II. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-78061-5_41

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  • DOI: https://doi.org/10.1007/978-3-642-78061-5_41

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-540-56442-3

  • Online ISBN: 978-3-642-78061-5

  • eBook Packages: Springer Book Archive

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