Columbia University has assembled an experienced team of investigators and staff with William T. Friedewald, MD as Principal Investigator to provide the expertise and resources necessary to serve as the Data Coordinating Center as requested in the RFA entitled: Cooperative Multicenter Traumatic Brain Injury Clinical Trials Network. There has been long standing awareness of the primary and secondary consequences of traumatic brain injury (TBI) with an estimated 50,000 deaths annually and 80,000 people permanently disabled. The research interest has focused on developing therapies that will reduce the significant acute phase mortality, that will minimze the secondary neurological injury, and that will improve the long-term functional outcome of those who survive. To these ends the NICHD proposes to fund a network of sites that will undertake clinical trials in both the acute and rehabilitation phases of TBI. The participants will be recruited from up to 8 clinical sites in the United States with a project period of 5 years. The Network Steering Committee faces some interesting challenges in designing and implementing such trials, including the need 1)to establishuniform case definitions and standards of care that will serve as, and will be uniformly accepted as, a basis for the quantitative evaluation of the proposed interventions, 2) to develop a scientifically rigorous, and feasible protocol for treating people acutely with TBI, and 3) to also develop another protocol that will evaluate either specific rehabilitation efforts or more broadly rehabilitationstrategies in the survivors of TBI. This will require the development of: i) training programs for the clinical site staffs generally and in the management of intracranial pressure, ii) a complex, web-based database that will allow the collection and management of data from the trials and that can then be shared among and between all of the Network participants, and iii) an infrastructure for the trials that will enable the addition of new research protocols. To meet these design and integration challenges our proposal offers a team of investigators with unusually experienced people in the key positions. These include the P.I.with his unusally diverse clinical trial research background, the Senior Statistician with his broad statistical experience and interest in clinical trial research, the Data Management Director with his extensive experience managing large data sets from clinical trials and other research efforts, and finally the clinical and research skills in TBI of our proposed clinical advisory team. The overall goal of our proposal is to provide the coordination of the multiple study sites, the data management and quality control activities, and the analytical and statistical support that will enable the Steering Committee and the NICHD to successfullyintegrate the Network sites and successfullycomplete the proposed clinicaltrials.
| 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 |
| 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 |
