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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD042738-03
Application #
6802873
Study Section
Special Emphasis Panel (ZHD1-RRG-K (07))
Program Officer
Ansel, Beth
Project Start
2002-09-05
Project End
2007-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
3
Fiscal Year
2004
Total Cost
$234,972
Indirect Cost
Name
Temple University
Department
Neurosurgery
Type
Schools of Medicine
DUNS #
057123192
City
Philadelphia
State
PA
Country
United States
Zip Code
19122
Abdelmalik, Peter A; Boorman, David W; Tracy, Joseph et al. (2016) Acute Traumatic Coagulopathy Accompanying Isolated Traumatic Brain Injury is Associated with Worse Long-Term Functional and Cognitive Outcomes. Neurocrit Care 24:361-70
Hart, Tessa; Novack, Thomas A; Temkin, Nancy et al. (2016) Duration of Posttraumatic Amnesia Predicts Neuropsychological and Global Outcome in Complicated Mild Traumatic Brain Injury. J Head Trauma Rehabil 31:E1-E9
Hart, Tessa; Benn, Emma K T; Bagiella, Emilia et al. (2014) Early trajectory of psychiatric symptoms after traumatic brain injury: relationship to patient and injury characteristics. J Neurotrauma 31:610-7
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
Hart, Tessa; Vaccaro, Monica J; Hays, Christina et al. (2012) Anger self-management training for people with traumatic brain injury: a preliminary investigation. J Head Trauma Rehabil 27:113-22
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
Elliott, Melanie B; Jallo, Jack J; Barbe, Mary F et al. (2009) Hypertonic saline attenuates tissue loss and astrocyte hypertrophy in a model of traumatic brain injury. Brain Res 1305:183-91
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
Hart, Tessa; Fann, Jesse R; Novack, Thomas A (2008) The dilemma of the control condition in experience-based cognitive and behavioural treatment research. Neuropsychol Rehabil 18:1-21