UK NETT Clinical Site Hub

This proposal describes the re-establishment of a Neurological Emergencies Treatment Trials (NETT Network Clinical Site Hub at the University of Kentucky Chandler Medical Center (UKCMC) in Lexington, Kentucky, in response to NIH/NINOS PAR-11-342. The overall goal of this proposal is to identify UKCMC as an academic medical facility with regional affiliate partners adept in "the evaluation of treatments for patients with a broad spectrum of neurological emergencies," The NETT Clinical Hub Site at UKCMC (UK NETT) has been a vigorous participant in the NETT Network since its competitive selection as one of the original 17 Network sites in 2007. During the past 4 years as a participating Clinical Hub Site, UK NETT has enrolled more than 87 subjects in the Phase III clinical trials undertaken within the NETT Network, to include RAMPART (midazolam v. lorazepam in status epilepticus), ALIAS Part 2 (albumin v. placebo in acute ischemic stroke), POINT (clopidogrelloading for stroke prevention after transient ischemic attack), and ProTECT (progesterone v. placebo in traumatic brain injury). Emergency Medicine is well represented within this venture, as the original and proposed UK NETT are based within the Department of Emergency Medicine at UKCMC. UK NETT is founded upon an intra-institutional collaboration that extends beyond Emergency Medicine to include physician faculty members in the Departments of Neurology, Neurosurgery, Surgery/Trauma Surgery, and Anesthesiology/lntensive Care Medicine. Regional affiliate medical care facilities aligned with UK NETT include "spoke" community hospitals located within Kentucky. The following Specific Aims are proposed: 1) To demonstrate the existence of an infrastructure for high-volume subject recruitment in "large, simple" clinical trials performed in acute-onset neurological disorders and 2) To demonstrate experience in successfully conducting clinical trials in acute-onset neurological disorders requiring rapid informed consent but also, when necessary, employing Exception from Informed Consent as regulated by the United States Food & Drug Administration.