Trial Outcomes & Findings for Transforming Research and Clinical Knowledge in TBI Pilot (NCT NCT01565551)

Last Updated: 2014-02-17

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

650 participants

Primary outcome timeframe

6 Months Post-Injury

Results posted on

2014-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	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): 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): No Interventions: Observational Study
Overall Study STARTED	586	51
Overall Study Clinical/Demographics	586	51
Overall Study Biospecimens/Biomarkers	479	22
Overall Study Neuroimaging	233	25
Overall Study 6-Month Outcomes	412	30
Overall Study COMPLETED	586	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transforming Research and Clinical Knowledge in TBI Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early-Presenting TBI: Acute Sites n=586 Participants 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): No Interventions: Observational Study	Late-Presenting TBI: Rehabilitation Center n=51 Participants This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC). N/A (Observational Study): No Interventions: Observational Study	Total n=637 Participants Total of all reporting groups
Age, Continuous	43.3 Years STANDARD_DEVIATION 18.5 • n=5 Participants	49.9 Years STANDARD_DEVIATION 20.4 • n=7 Participants	43.9 Years STANDARD_DEVIATION 18.7 • n=5 Participants
Sex: Female, Male Female	167 Participants n=5 Participants	14 Participants n=7 Participants	181 Participants n=5 Participants
Sex: Female, Male Male	419 Participants n=5 Participants	37 Participants n=7 Participants	456 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	22 Participants n=5 Participants	2 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	17 Participants n=5 Participants	0 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	9 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) White	471 Participants n=5 Participants	39 Participants n=7 Participants	510 Participants n=5 Participants
Race (NIH/OMB) More than one race	21 Participants n=5 Participants	0 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	84 Participants n=5 Participants	5 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	495 Participants n=5 Participants	33 Participants n=7 Participants	528 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months Post-Injury

Outcome measures

Outcome measures
Measure	Early-Presenting TBI: Acute Sites n=414 Participants 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): No Interventions: Observational Study	Late-Presenting TBI: Rehabilitation Center n=28 Participants This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC). N/A (Observational Study): No Interventions: Observational Study
Glasgow Outcome Scale Extended (GOSE)	7 Glasgow Outcome Scale Extended (GOSE) Interval 5.0 to 8.0	5 Glasgow Outcome Scale Extended (GOSE) Interval 4.0 to 7.0

Adverse Events

Early-Presenting TBI: Acute Sites

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Late-Presenting TBI: Rehabilitation Center

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Geoffrey Manley, MD, PhD

University of California, San Francisco

Phone: 415-206-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place