Transforming Research and Clinical Knowledge in TBI Pilot

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01565551
First received: March 24, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

The global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The investigators will create and expand existing data repositories for patient demographics, neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing researchers and clinicians with the infrastructure to establish multidisciplinary, multicenter research networks and improve clinical research in the TBI field.


Condition Intervention
Traumatic Brain Injury
Other: N/A (Observational Study)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Glasgow Outcome Scale Extended (GOSE) [ Time Frame: 6 Months Post-Injury ] [ Designated as safety issue: No ]
    The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.


Biospecimen Retention:   Samples With DNA

Whole blood for genetic analysis. Plasma for proteomic analysis.


Enrollment: 650
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early-Presenting TBI: Acute Sites
This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).
Other: N/A (Observational Study)
No Interventions: Observational Study
Late-Presenting TBI: Rehabilitation Center
This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).
Other: N/A (Observational Study)
No Interventions: Observational Study

  Hide Detailed Description

Detailed Description:

The Investigators aim for a 10-month data collection period for TBI patients across the spectrum from concussion to coma with a limited 3-month follow up and extensive 6-, 12-, and 24-month follow ups. Patient enrollment will occur in three high-volume TBI Centers (SFGH, UPMC, UMCB) and a TBI Rehabilitation Center (MSMC). These Centers have a long track record of multi-center TBI research experience as well as existing infrastructure for rapid start-up and sustained enrollment. All patients admitted acutely with a history of external force injury to the head with a head CT performed in the emergency department are eligible for enrollment. Head CTs are performed according to the American College of Emergency Physicians (ACEP) and the Centers for Disease Control and Prevention (CDC) Guidelines for neuroimaging and decision making in TBI. These Guidelines are already in place at the participating Centers and are used to determine which patients will receive a non-contrast head CT scan as part of their initial evaluation. Patients will not be excluded based on age, race, gender, ethnicity, substance abuse, or prior psychiatric history to provide a population-based sample of of TBI subjects across the injury spectrum from concussion to coma.

Study Components (Ref: NIH-NINDS TBI Common Data Elements):

  1. Clinical Care and Demographic Data Collection. Variables include: date and time of injury, mechanism of injury, acute laboratory values and vital signs, neurological evaluations, surgical interventions, hospital course, morbidity and mortality during acute care.
  2. Blood Draw for Proteomic and Genetic Marker Analyses. Blood samples will be drawn within 24 hours of injury. Plasma will be spun and separated from whole blood. Both plasma and whole blood samples will be banked centrally under -80 degrees Celsius at the University of California, San Francisco (UCSF) DNA Bank.
  3. 3-Tesla (3T) Magnetic Resonance Imaging. A 3T Research MRI will be completed on a subset of patients able to return 1-2 weeks post-injury.
  4. 3-Month Follow Up. The Glasgow Outcome Scale - Extended (GOS-E) and neurological symptoms inventory will be administered to patients over the phone 3 months post-injury.
  5. 6-, 12-, and 24-Month Neurocognitive Assessment. Standardized measures from all designated CORE domains for outcome after TBI by TBI-CDEs, which include: global recovery, functional outcome, psychological impairment, post-traumatic stress disorder (PTSD), and quality of life, will be administered to the participant.

The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI.

Recent Publications:

Yue JK, Vassar MJ, Lingsma H, Cooper SR, Yuh EL, Mukherjee P, Puccio AM, Gordon W, Okonkwo DO, Valadka A, Schnyer DM, Maas A, Manley GT; TRACK-TBI Investigators. Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury. J Neurotrauma. 2013 Nov 15;30(22):1831-44.

Dams-O'Connor K, Spielman L, Singh A, Gordon WA, Lingsma HF, Maas AI, Manley GT, Mukherjee P, Okonkwo DO, Puccio AM, Schnyer DM, Valadka AB, Yue JK, Yuh EL; TRACK-TBI Investigators. The Impact of Prior Traumatic Brain Injury on Health and Functioning: a TRACK-TBI Study. J Neurotrauma. 2013 Dec 15;30(24):2014-20.

McMahon PJ, Hricik AJ, Yue JK, Puccio AM, Inoue T, Lingsma H, Beers SR, Gordon W, Valadka, A, Manley GT, Okonkwo DO; TRACK-TBI Investigators. Symptomatology and Functional Outcome in Mild Traumatic Brain Injury: Results from the Prospective TRACK-TBI Study. J Neurotrauma. 2013 Oct 31. [Epub ahead of print]

Diaz-Arrastia R, Wang KK, Papa L, Sorani MD, Yue JK, Puccio AM, McMahon PJ, Inoue T, Yuh EL, Lingsma H, Maas A, Valadka A, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Acute Biomarkers of Traumatic Brain Injury: Relationship Between Plasma Levels of Ubiquitin C-Terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP). J Neurotrauma. 2013 Oct 9. [Epub ahead of print]

Okonkwo DO, Yue JK, Puccio AM, Panczykowski D, Inoue T, McMahon PJ, Sorani MD, Yuh EL, Lingsma H, Maas A, Valadka A, Manley GT; TRACK-TBI Investigators. GFAP-BDP as an Acute Diagnostic Marker of Traumatic Brain Injury: Results from the Prospective TRACK-TBI Study. J Neurotrauma. 2013 Sep 1;30(17):1490-7.

Yuh EL, Mukherjee P, Lingsma HF, Yue JK, Ferguson AR, Gordon WA, Valadka AB, Schnyer DM, Okonkwo DO, Maas AI, Manley GT; TRACK-TBI Investigators. Magnetic Resonance Imaging Improves 3-Month Outcome Prediction in Mild Traumatic Brain Injury. Ann Neurol. 2013 Feb;73(2):224-35.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a population-based TBI study. All patients presenting to the acute sites with traumatic brain injury and receive a head CT scan as part of standard care within 24 hours of injury date and time are initially eligible. As most six-month Common Date Elements (CDE) outcome measures are normed and validated only in English, study participants must be English-speaking. There are no other restrictions to eligibility.

Criteria

Inclusion Criteria:

  • Presentation to Emergency Department < 24 hours post-injury
  • Head CT scan for Traumatic Brain Injury (TBI) as part of regular care.
  • English Speaking

Exclusion Criteria:

  • Presentation to Emergency Department > 24 hours post-injury
  • Custody or Incarceration
  • 5150 Psychiatric Hold

Component-Specific Exclusion Criteria:

MRI: Pregnant or may be pregnant; younger than 8 years old; those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, intrauterine devices (IUDs), or metal objects in their body, especially in the eye. Persons with a history of claustrophobia are excluded from this procedure.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565551

Locations
United States, California
San Francisco General Hospital (SFGH)
San Francisco, California, United States, 94110
United States, New York
Mount Sinai Rehabilitation Center
New York, New York, United States, 10029
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University Medical Center, Brackenridge
Austin, Texas, United States, 78701
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Geoffrey T Manley, MD, PhD University of California, San Francisco (San Francisco, CA)
Principal Investigator: David O Okonkwo, MD, PhD University of Pittsburgh Medical Center (Pittsburgh, PA)
Principal Investigator: Alex B Valadka, MD University Medical Center, Brackenridge (Austin, TX)
Principal Investigator: Wayne A Gordon, PhD Mount Sinai Rehabilitation Center (New York, NY)
  More Information

Additional Information:
Publications:
Foulkes AM, Eisenberg MH, Jane AJ. The Traumatic Coma Data Bank; design, methods and baseline characteristics. J. Neuroch. 75, S1-S15, 1991
Ng J, Wahl M, Tong L, Lee H, Veeraraghavan S, Xu D, Zhao S, Kornak J, Meeker M, Ghajar J, Manley GT, Mukherjee P. 3T Diffusion Tensor Imaging of Mild Traumatic Brain Injury: A Prospective Longitudinal Study. Proc ISMRM 2009; 641.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01565551     History of Changes
Other Study ID Numbers: RC2NS069409, RC2NS069409
Study First Received: March 24, 2012
Results First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Traumatic Brain Injury
Common Data Elements
Prognostic Models
Neuroimaging
Biomarkers
Genetic Variants
Concussion
Psychological Health

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 23, 2014