Transforming Research and Clinical Knowledge in TBI Pilot

NCT ID: NCT01565551

Last Updated: 2014-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

N/A (Observational Study)

Intervention Type: OTHER

No Interventions: Observational Study

Late-Presenting TBI: Rehabilitation Center

This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).

N/A (Observational Study)

Intervention Type: OTHER

No Interventions: Observational Study

Interventions

N/A (Observational Study)

No Interventions: Observational Study

Intervention Type: OTHER

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

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey T Manley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco (San Francisco, CA)

David O Okonkwo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Alex B Valadka, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center, Brackenridge (Austin, TX)

Wayne A Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Rehabilitation Center (New York, NY)

Locations

San Francisco General Hospital (SFGH)

San Francisco, California, United States

Mount Sinai Rehabilitation Center

New York, New York, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

University Medical Center, Brackenridge

Austin, Texas, United States

Countries

United States

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Diaz-Arrastia R, Wang KK, Papa L, Sorani MD, Yue JK, Puccio AM, McMahon PJ, Inoue T, Yuh EL, Lingsma HF, Maas AI, Valadka AB, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Acute biomarkers of traumatic brain injury: relationship between plasma levels of ubiquitin C-terminal hydrolase-L1 and glial fibrillary acidic protein. J Neurotrauma. 2014 Jan 1;31(1):19-25. doi: 10.1089/neu.2013.3040. Epub 2013 Oct 9.

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Yue JK, Vassar MJ, Lingsma HF, Cooper SR, Okonkwo DO, Valadka AB, Gordon WA, Maas AI, Mukherjee P, Yuh EL, Puccio AM, Schnyer DM, Manley GT; TRACK-TBI Investigators. Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury. J Neurotrauma. 2013 Nov 15;30(22):1831-44. doi: 10.1089/neu.2013.2970. Epub 2013 Sep 24.

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Other Identifiers

RC2NS069409

Identifier Type: NIH

Identifier Source: secondary_id

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RC2NS069409

Identifier Type: NIH

Identifier Source: org_study_id

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