BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

To date, there is no commercially available blood test approved in the United States for use
as an aid in the assessment and diagnosis of stroke. There have been various reports in the
scientific literature describing the ability of various biomarkers to predict or identify
stroke, with varied success. A biomarker panel approach, similar to that used for the
evaluation of chest pain patients (troponin I, CK-MB, and myoglobin) enhances diagnostic
accuracy, particularly when the panel includes protein markers associated with various
components of the disease pathophysiology. This study involves a retrospective analysis of
data collected from patients that present with an acute focal neurological deficit,
suspected cerebral ischemia, or suspected intracranial hemorrhage within 24 hours of symptom
onset or last known well time will be enrolled into the study. Blood samples will be
collected at enrollment and serially up to 72 hrs. from the time of onset or last known well
time. The study population will also include a subset of patients with subarachnoid
hemorrhage, who will have additional samples collected daily from day 3 through day 14 (at
clinical sites participating in the vasospasm substudy) for the evaluation of cerebral
vasospasm. The patient's participation in the study is complete when all samples have been
collected or when they are discharged from the hospital, whichever occurs first. All blood
sample will be analyzed using the Triage Stroke Panel test. Measurements will be performed
at each clinical site and at Biosite (subject to test device availability). In order to
minimize bias and eliminate significant risk to the patient, physicians will be blinded to
all Triage Stroke Panel results during the course of the study. Completed case report forms
(CRFs) and frozen plasma samples will be transferred to Biosite.

Inclusion Criteria:

Age 18 and above Cerebral ischemia or intracranial hemorrhage suspected Enrollment within
24 hrs from symptom onset or last well-known time

Exclusion Criteria: