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Traumatic Brain Injury Clinical Trials (TBI-CT) Network

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Overview

TBI is a leading cause of death and disability in children and adults. Improvements in treatment and care have increased survival rates for those with TBI, while also increasing the rates of TBI patients with persistent physical, cognitive, behavioral and social deficits. Despite dramatic increases in our understanding of TBI during the past two decades, there is still much to learn about this complex condition.

The NICHD’s National Center for Medical Rehabilitation Research (NCMRR) established the TBI-CT Network in 2002 to conduct multicenter observational studies and clinical trials of patients with TBI. The overarching goal of the network is to:

  • Evaluate acute and rehabilitative interventions for efficacy, safety, and cost-effectiveness;
  • Study the interaction between acute care practice and rehabilitation strategies; and
  • Follow patients to assess long-term functional outcomes.

Researchers in the TBI-CT Network are still conducting data analyses and other activities related to Network studies, but the Network itself is not currently receiving additional NICHD funding.

The TBI-CT Network included research teams at eight sites and a Data Coordinating Center (DCC). Staff from the NCMRR’s Traumatic Brain Injury (TBI) and Stroke Rehabilitation (TSR) Program provided scientific oversight for the Network.

Topic Areas

One of the primary activities of the TBI-CT Network was to create a working definition of TBI. In addition, the Network aimed to:

  • Evaluate the relationship between acute care practice and rehabilitation strategies to long-term functional outcome
  • Improve treatment
  • Improve outcomes
  • Evaluate safety and efficacy of interventions

Other research topics studied through the TBI-CT Network included (but were not limited to):

  • Development of a TBI patient profile, including clinical features using the definition of TBI
  • Development of clinical treatment guidelines and procedures for all points in the continuum of care for TBI patients, including:
    • Guidelines for surgical care
    • Systems-based protocol for severe and moderate TBI patients
    • Deep-vein thrombosis prophylaxis procedures
    • Rehabilitation guidelines for physical therapy, speech-language pathology, occupational therapy, and neuropsychology
  • Development of acute intervention, genetics, behavioral rehabilitation, and depression protocols for TBI patients to provide statistically valid results of treatment effectiveness and answer important clinical questions in a cost-effective and efficient manner

In addition, Network researchers initiated and successfully enrolled patients in the Citicoline Brain Injury Trial (COBRIT) to evaluate the effect of 90 days of citicoline on the functional outcomes of patients with complicated mild, moderate, and severe TBI. Citicoline, a compound found throughout the body, offers potential neuroprotective properties as well as facilitating neurorepair post injury. Citicoline was approved for use in TBI in 59 countries. COBRIT is a two-arm, double-blind, placebo-controlled, phase III, multicenter trial that employs stringent neuroimaging and clinical criteria to assure accurate enrollment. Functional outcomes are assessed at 30, 90, and 180 days after injury. A corollary study is evaluating the role of genetic markers to establish a TBI genetics database. Analysis of data from COBRIT and the related study are currently underway; findings will be published once the analysis is complete. For more information on COBRIT, visit http://www.ncbi.nlm.nih.gov/pubmed/19803786.

Funded Sites

The TBI-CT Network no longer receives funding, but data analysis activities are ongoing. Funded clinical sites within the Network included:

  • Temple University
  • University of Alabama, Birmingham
  • University of Pittsburgh
  • University of Washington
  • University of Maryland School of Medicine
  • University of Tennessee Health Science Center
  • University of Texas-Southwestern Medical Center
  • Virginia Commonwealth University

Columbia University served as the DCC for the Network.

More Information

Last Updated Date: 10/15/2012
Last Reviewed Date: 10/15/2012
Vision National Institutes of Health Home BOND National Institues of Health Home Home Storz Lab: Section on Environmental Gene Regulation Home Machner Lab: Unit on Microbial Pathogenesis Home Division of Intramural Population Health Research Home Bonifacino Lab: Section on Intracellular Protein Trafficking Home Lilly Lab: Section on Gamete Development Home Lippincott-Schwartz Lab: Section on Organelle Biology