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| ID | Type | Description | Link |
|---|---|---|---|
| NIH UL1TR000117 | Other Identifier | University of Kentucky CCTS High Impact Award |
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| Name | Class |
|---|---|
| University of Kentucky | OTHER |
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In the search for a novel marker of stroke that could be rapidly assessed in blood, the investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15 min) detects levels of a biomarker that is released into blood following neuronal injury associated with stroke and traumatic brain injury. The protein's expression in human brain should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.
The use of a lateral flow device (LFD) to indicate the presence of a blood biomarker is feasible and may provide an important diagnostic tool for stroke and traumatic brain injury (TBI).
Primary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral Flow Device | Experimental | Determine the feasibility of testing whole blood samples from patients with acute stroke (both ischemic and hemorrhagic) and traumatic brain injury being evaluated in the Emergency Department and Inpatient Services at University of Kentucky. No diagnostic or treatment decisions will be based on the results for any patient and the patient will not be told of the results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lateral Flow Device | Device | A drop of whole blood from a finger stick is placed on the lateral flow device at two different time points to indicate the presence of a neuronal specific biomarker. The results will also be correlated to severity of clinical and radiographic injury. Separate drops are evaluated similarly for serum levels. The objective is to determine feasibility of a diagnostic tool for stroke (ischemic and hemorrhagic and traumatic brain injury (TBI). No diagnostic results or resulting treatments will be applied to any subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole Blood Biomarker Results on the Visual Analog Scale | Degree of response to a protein specific biomarker in whole blood as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe. | Within 8 hours of time of injury/onset of stroke symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole Blood Biomarker Results on the Visual Analog Scale | Degree of response to a protein specific biomarker in whole blood as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe. | Within 48 ± 8 hours of time of injury/onset of stroke symptoms. |
| Serum Biomarker Results on the Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin F. Fraser, MD | University of Kentucky Department of Neurological Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital | Lexington | Kentucky | 40536-0298 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Degree of response to a protein specific biomarker in serum as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe. |
| Within 8 hours of time of injury/onset of stroke symptoms. |
| Serum Biomarker Results on the Visual Analog Scale | Degree of response to a protein specific biomarker in serum as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe. | Within 48 ± 8 hours of time of injury/onset of stroke symptoms. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |