The proposed SBIR program aims to develop a rapid point-of-care (POC) prognosticative assay device that provides clinically actionable data to predict onset of high intracranial pressure (HICP) after a severe traumatic brain injury (sTBI). Delayed onset of HICP is a manifestation of secondary injury leading to poor patient outcome following TBI after a severe closed head injury. Early and even preemptive decompressive craniectomy prevents HICP onset and significantly improves outcome in severe TBI patients. Often, a lack of clinically actionable prognosticative information severity forces clinicians to be reactive than proactive in treating sTBI-associated HICP onset. Our proposed SBIR research and commercialization program is to develop a blood and CSF POC neuromonitoring device to predict and identify sTBI patients who will experience delayed HICP onset later. The POC device is based on microfluidic solid phase immunoassay (?fSPIA) principles, which permit rapid kinetics due to large surface area to volume ratios within the assay channels. We envision that resulting prognostic data will be actionable for clinicians in identifying sTBI patients at strong risk of delayed HICP onset. Based on the near-real time information clinicians can initiate a preemptive decompressive craniectomy and improve clinical outcomes. We have identified seven "lead "biomarker proteins that are associated with sTBI in humans. Our Preliminary Studies also indicate their utility in predicting TBI-induced HICP onset. The proposed Phase I SBIR feasibility study will employ the ?fSPIA POC platform to measure our four candidate TBI biomarkers in serum from TBI rats. ELISA will be our "gold standard" comparator. We will use the controlled cortical impact-induced severe TBI rat model for these studies. Early measures of serum biomarkers will be employed to predict edema by Day 3 after severe TBI.
Our Aims are:
Aim 1 : Develop and validate the ?fSPIA POC method for each of the seven TBI candidate biomarkers employing a traditional ELISA as the gold standard.
Aim 2 : Determine early time point changes in serum biomarker levels employing the ?fSPIA POC method and correlate it to changes in brain edema at later time point in rats with severe TBI.

Public Health Relevance

Delayed onset of high intracranial pressure is a manifestation of secondary injury leading to poor patient outcome after a severe traumatic brain injury. The proposed SBIR program aims to develop a rapid point-of-care prognosticative assay device that provides clinically actionable data by the patient bedside to predict onset of high intracranial pressure after a severe traumatic brain injury. This will assist clinicians to identify patients "a risk" for high intracranial pressure early and take proactive neurosurgical approaches to improve patient outcome.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43NS076107-01A1
Application #
8312928
Study Section
Special Emphasis Panel (ZRG1-ETTN-K (10))
Program Officer
Fertig, Stephanie
Project Start
2012-07-01
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
1
Fiscal Year
2012
Total Cost
$348,668
Indirect Cost
Name
P2, Inc.
Department
Type
DUNS #
182472162
City
Cincinnati
State
OH
Country
United States
Zip Code
45242