Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
Completed · Not applicable
Conditions studied: Ischemic Stroke, Hemorrhagic Stroke, Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT02514902
- Run by
- Justin Fraser
- People needed
- 48
- Starts
- 2015-03-25
- Expected to finish
- 2016-12-16
- Last updated by the study team
- 2017-02-23
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients 21-85 years old, male or female.
- Suspected TBI, acute ischemic stroke, or nontraumatic/nonlesional intracerebral hemorrhage (ICH) based on clinical and radiographic evidence as determined and documented by the appropriate service (Trauma Service or Neurosurgery Service for TBI; Neurology or Neurosurgery Service for Stroke) at University of Kentucky.
- Patients with impaired capacity may be included; as the pathology to be studied (stroke or TBI) may impair their capacity (please see attached required documentation regarding impaired capacity).
You may not qualify if…
- Pregnant women as the effect of pregnancy on the biomarker testing result is as yet unknown.
- While patients may be included with the above listed diagnoses, they may be excluded later if an alternate unlisted diagnosis is found to be the root cause of their presentation. An example would be a patient initially thought to have a stroke, who is discovered to be suffering from a seizure instead.
Where it is running
- University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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