Long Term Clinical Correlates of TBI: Imaging, Biomarkers, Clinical Phenotyping
Long Term Clinical Correlates of TBI: Imaging, Biomarkers, Clinical Phenotyping
批准号:
8952872
负责人:
Leighton Chan
金额:
$0.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
AcuteAddressAgeAmendmentAreaBiological MarkersBloodCellsClinicalCognitiveCohort StudiesCollaborationsCommon Data ElementCommunicationCommunitiesDataDatabasesEnrollmentEyeFutureGenerationsImageInjuryInstitutional Review BoardsMagnetic Resonance ImagingMeasuresNatural HistoryOutcomeOutcome MeasurePathologyPatientsPhenotypePositron-Emission TomographyProtocols documentationRecruitment ActivityResearchResearch PersonnelResourcesSalivaSeriesSeveritiesSupport GroupsTaxonomyTestingTraumaTraumatic Brain InjuryUniversitiesWashingtonbasebiobankclinical phenotypecohortinclusion criteriaoutreachprospective
中文摘要
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英文摘要
This study received CNS IRB Blue approval on March 17, 2010. The study team is fully staffed and we are actively recruiting patients for this protocol.
In July 2011 we received IRB approval for a sub study that broadens the study inclusion criteria up to 5 years since injury. The sub-study will focus on collecting primarily the TBI Common Data Elements (CDEs), bloods, and imagining.
In June 2012 the IRB approved expanding our enrollment age range from 18-70, to 18 and older. This same amendment exchanged PET-CT for PET-MRI in the imaging section of the protocol. A section regarding offered treatment was added to address the needs of those subjects who have functional needs with limited access to community resources.
To date, this study has enrolled 127 patients, 74 of which are enrolled in the prospective cohort study and followed longitudinally. Previous recruitment challenges have been addressed with the expansion of a formulized recruitment effort and the opening of communication between the Recruitment Core and the Acute TBI Protocol under Dr. Larry Latour. Our research team has also been engaged in outreach to the community via support groups, and has initiated discussions around more formal collaborations with other TBI experts in the area, including new trauma teams in the area, such as George Washington University
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