BANDITS Severe TBI Study DesignBANDITS Severe TBI Study Design

Severe TBI Subjects (n=200)• Aged 18+

• GCS ≤ 8• Require ventriculostomy and neuromonitoring as part of routine

care• 24 hour waiver of informed consent

CSF Controls (n=50)• Aged 18+• No injuries – spinal anesthesia for routine surgical procedures• Or access to CSF for treatment of hydrocephalus or meningitis

Normal Controls(n=50)• Aged 18+

• Multiple injuries without brain injury

Feasibility Study for FDA Feasibility Study for FDA SubmissionSubmission

TBI CSF Controls Normal Controls

NumberMalesFemales

4634 (73.9%)12 (26.1%)

1029 (65.9%)15 (34.1%)

6426 (40.6%)38 (59.4%

Age:AverageStd DevMinimumMaximum

Race:CaucasianBlackAsianOther

50.219.54

1988

451

58.2 1, 2

20.522382

38 (86.4%)6 (13.6)

30.09 2, 3

15.421874

52 (81.2%)4 (6.3%)

7 (10.9%)1 (1.6%)

GCS in Emergency DepartmentAverageStd Dev

5.31.9

Subject DemographicsSubject Demographics

Case Study: Subject UF-006Case Study: Subject UF-006• 52 Year Old Caucasian Woman

• Hit-and-run while on motorcycle with no helmet

• GCS

• CT revealed SAH and facial fractures

• Ventriculostomy removed after 5 days• Good outcome

• On admission = 3• Best in First 24 Hours = 8• After 10 days = 11

• Marshall Scale = II• Rotterdam Scale = 2