For over thirty years, the Virginia Commonwealth University's Medical College of Virginia Hospital (VCU/MCVH) has been active in brain injury research and has contributed to what is now known about its pathophysiological mechanisms and established the value of early, aggressive neurosurgical intervention. Advances in surgical techniques, management of intracranial pressure, and pharmacological approaches to acute care management helped the Division of Neurosurgery and VCU/MCVH attain international recognition as a research and clinical center. Since the mid-1970s, the Department of Physical Medicine and Rehabilitation (PM&R) has collaborated actively with the Division of Neurosurgery to develop innovative, interdisciplinary approaches to providing optimal care to patients with a traumatic brain injury (TBI). These collaborations have demonstrated the importance of early treatment decisions on long-term outcome. Advances made in the past decade by PM&R include the creation of a uniform head injury database, an extended system of care, new partnerships with service providers and advocacy organizations, validation of improved outcome measures, and collaboration with other model systems programs and databases in evaluating the costs, outcomes, and benefits of service. This application is the investigators' response to RFA-HD-01-007 to participate under a cooperative agreement as a Clinical Network Site. As a member site of the TBI Network, they will collaborate with other members, the Data Coordinating Center and project scientists of the National Institute of Child Health and Human Development to develop, implement, and assess research protocols, interventions, and evaluation strategies for patients with a moderate or severe TBI. As requested in the RFA, they have included a """"""""concept protocol"""""""" which briefly outlines a randomized, placebo-controlled trial to test the safety, tolerability, and pharmacokinetics of a single intravenous infusion of Cyclosporin A in patients with a severe TBI.
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| Zafonte, Ross D; Bagiella, Emilia; Ansel, Beth M et al. (2012) Effect of citicoline on functional and cognitive status among patients with traumatic brain injury: Citicoline Brain Injury Treatment Trial (COBRIT). JAMA 308:1993-2000 |
| Bagiella, Emilia; Novack, Thomas A; Ansel, Beth et al. (2010) Measuring outcome in traumatic brain injury treatment trials: recommendations from the traumatic brain injury clinical trials network. J Head Trauma Rehabil 25:375-82 |
| Zafonte, Ross; Friedewald, William T; Lee, Shing M et al. (2009) The citicoline brain injury treatment (COBRIT) trial: design and methods. J Neurotrauma 26:2207-16 |
