The Temple University Hospital (TUH) and Drucker Brain Injury Center (DBIC) consortium proposes to become a Clinical Trials Network site. Located in a low-income area of North Philadelphia, TUH serves a diverse population with a significant proportion of African-American and Hispanic patients. It is one of the busiest Level 1 trauma centers in the state and annually treats approximately 100 moderate to severe head injury patients - both adult and pediatric. Dr. Narayan, who chairs the Neurosurgery Department, has a career-long commitment to TBI research and is extensively published in the area. He currently chairs the American Brain Injury Consortium. TUH has a dedicated 8-bed Neurosurgical ICU (NICU) with experienced nurses who have worked with research protocols for years. The neurosurgical team has complete and primary control of the patients in the NICU and is therefore very closely involved in their management. Comprehensive monitoring capability is already in place and an excellent full-time research coordinator is on staff. The adult and pediatric hospital buildings are adjacent to each other and are connected by a cross walk. The same resident team covers both age groups. There is an excellent working relationship between the Neurosurgery team, the Trauma Surgery team and other associated services. Once patients are ready for rehabilitation, they are transferred to the Drucker Brain Injury Center (DBIC) at Moss Rehab located just a mile from TUH on the same street. This facility is recognized as one of the best rehab hospitals in the country in large part due to the Drucker Brain Injury Center. DBIC houses a 27-bed inpatient unit exclusively for patients with TBI. Approximately 300 patients are admitted to the inpatient service at DBIC and over 400 participate in the post-acute programs. Dr. Tessa Hart, a neuropsychologist who has specialized in TBI for over 20 years, has established, along with John Whyte, MD, PhD, a long-term follow up system (83% at 1 year and 73% at 2 years). The formal academic relationship in TBI research between Moss and TUH dates back to 1997 when a Moss Rehab-Temple consortium was awarded an NIDRR grant as a TBI Model System. This system has functioned successfully since then with a clear emphasis on the rehabilitation phase of TBI. The proposed Clinical Trials Network would therefore fit in with the Model System by now addressing the acute management of TBI patients. A brief concept protocol has been proposed to study the use of hypertonic saline in the treatment of patients with severe TBI. There is an extensive body of scientific literature that suggests that hypertonic saline may be superior to the traditionally used normal saline in the treatment of TBI. Normal saline and hypertonic saline will be compared in a Phase II prospective, randomized, stratified, non-blinded study. This study has been designed to assess safety and to look for early evidence of efficacy in reducing the percentage of time that each group spends with an ICP of over 20 mm Hg. Assuming encouraging findings in this study, a Phase III trial will be undertaken.
