Ischemic StrokeSTABILISER-INCT02514902
Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
A study testing Lateral Flow Device in people with Ischemic Stroke and Hemorrhagic Stroke, run by Justin Fraser at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke, Traumatic Brain Injury
- What is being tested?
- Lateral Flow Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2015to 16 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
Lexington, Kentucky, 40536-0298
About this study
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.
Read the detailed description
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:
- Determine the first-in-humans feasibility using the investigators' biomarker lateral flow device on whole blood samples to diagnose 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. Provide initial pilot data for estimating sensitivity and specificity of the assay.
- Establish a visual ordinal grading scale that is easy to use clinically to judge the severity of injury, from the Lateral Flow Device result. Verify that the visual scale has inter-rater reliability, and evaluate it against a digital detection assay.
- Examine the correlation between clinical and radiographic parameters of injury severity and blood levels of the biomarker. The investigators will correlate the results of the test with NIH Stroke Scale and with MRI infarct volume for ischemic stroke, with hemorrhage volume on CT for hemorrhagic stroke, and with Glasgow Coma Scale for Traumatic Brain Injury (TBI).
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke, Traumatic Brain Injury
- Being tested
- Lateral Flow Device
- Keywords
- Lateral Flow Device (LFD), Acute Stroke, Traumatic Brain Injury (TBI), Point of Care (POC), Biomarker
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Flow DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lateral Flow Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 8 hours of time of injury/onset of stroke symptoms.
Secondary outcomes (3)
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.
Measured: Within 48 ± 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.
Measured: 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.
Measured: Within 48 ± 8 hours of time of injury/onset of stroke symptoms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study start25 Mar 2015
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justin Fraser
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor-investigator, Justin Fraser, University of Kentucky
- Investigators
- Justin F. Fraser, MD, Principal investigator, University of Kentucky Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514902
- Sponsor's protocol ID
- 15-0166-F6A
- Other IDs
- NIH UL1TR000117
- Acronym
- STABILISER-I
- Status last verified
- Feb 2017
- First submitted
- 29 Jul 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
- ClinicalTrials.gov ID
- NCT02514902
- Acronym / sponsor ID
- STABILISER-I / 15-0166-F6A
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke, Traumatic Brain Injury
- Keywords
- Lateral Flow Device (LFD), Acute Stroke, Traumatic Brain Injury (TBI), Point of Care (POC), Biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Justin FraserUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Determine the first-in-humans feasibility using the investigators' biomarker lateral flow device on whole blood samples to diagnose 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. Provide initial pilot data for estimating sensitivity and specificity of the assay.
- Establish a visual ordinal grading scale that is easy to use clinically to judge the severity of injury, from the Lateral Flow Device result. Verify that the visual scale has inter-rater reliability, and evaluate it against a digital detection assay.
- Examine the correlation between clinical and radiographic parameters of injury severity and blood levels of the biomarker. The investigators will correlate the results of the test with NIH Stroke Scale and with MRI infarct volume for ischemic stroke, with hemorrhage volume on CT for hemorrhagic stroke, and with Glasgow Coma Scale for Traumatic Brain Injury (TBI).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral Flow Device | Experimental | Device: Lateral Flow DeviceDetermine 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Flow DeviceA 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. | Device | Lateral Flow Device |
Primary outcome
Whole Blood Biomarker Results on the Visual Analog Scale
Time frame: Within 8 hours of time of injury/onset of stroke symptoms.
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.
3 secondary outcomes
Whole Blood Biomarker Results on the Visual Analog Scale
Time frame: Within 48 ± 8 hours of time of injury/onset of stroke symptoms.
Serum Biomarker Results on the Visual Analog Scale
Time frame: Within 8 hours of time of injury/onset of stroke symptoms.
Serum Biomarker Results on the Visual Analog Scale
Time frame: Within 48 ± 8 hours of time of injury/onset of stroke symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin F. Fraser, MD principal investigator
University of Kentucky Department of Neurological Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Flow Device in people with Ischemic Stroke and Hemorrhagic Stroke, run by Justin Fraser at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Blood Biomarker Results on the Visual Analog Scale (time frame: Within 8 hours of time of injury/onset of stroke symptoms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.