CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,996 enrolled
Drug / intervention
In-Person Outcome Assessment +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02119182
NCT02119182N/ACompleted
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury

University of California, San Francisco·observational·Posted Apr 21, 2014·Updated Sep 16, 2020

In Brief

An observational study evaluating In-Person Outcome Assessment, Phone Outcome Assessment, and 2 other interventions for Traumatic Brain Injury. Completed, enrolled 2,996 participants across 23 sites.

Detailed Summary

The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial design. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-TBI site with a brain injury that meets ACRM criteria and receives a clinically indicated head CT.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), Department of Health and Human Services

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartMar 2, 2014
Primary CompletionJun 22, 2019
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.2 years ago

Interventions

In-Person Outcome Assessmentbehavioral

NIH Flexible Outcome Assessment Battery Framework Measures In-Person at 2 Weeks, 6 Months, and 12 Months, and by Phone at 3 Months.

Phone Outcome Assessmentbehavioral

NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.

3T Magnetic Resonance Imaging (MRI)procedure

3T Research MRI at 2 weeks and 6 months.

Blood Draw for Plasma, DNA, Serum, RNAprocedure

Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).