Ischemic StrokeNCT02809651
Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
A study testing Infrascanner in people with Ischemic Stroke and Brain Tumor, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke, Brain Tumor, Brain Surgery
- What is being tested?
- Infrascanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2016to Feb 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with ischemic stroke diagnosed by clinical examination and CT-scan
- Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI
- Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan
- Patients that have undergone brain surgery
- Patients with a normal CT-scan of the brain after head trauma
- Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.
Read the detailed description
Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).
Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.
- Conditions
- Ischemic Stroke, Brain Tumor, Brain Surgery, Intracranial Hemorrhage, Headache, Head Trauma
- Being tested
- Infrascanner
- Keywords
- Infrascanner, Intracranial hemorrhage
- Medical subject headings
- Ischemic Stroke, Brain Neoplasms, Intracranial Hemorrhages, Headache, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfrascannerDevice
bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke | Experimental | patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan Receives: Device: Infrascanner |
| Brain tumor | Experimental | patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI Receives: Device: Infrascanner |
| Brain surgery | Experimental | patients that have undergone brain surgery Receives: Device: Infrascanner |
| Intracranial hemorrhage | Active comparator | patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan Receives: Device: Infrascanner |
| Headache | Experimental | patients with headache complaints and a normal CT-scan of the brain Receives: Device: Infrascanner |
| Headtrauma | Experimental | patients with head trauma and a normal CT-scan of the brain Receives: Device: Infrascanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Vanelderen, Ziekenhuis Oost-Limburg
- Investigators
- Pascal Vanelderen, MD, PhD, Principal investigator, member of Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809651
- Sponsor's protocol ID
- 16/015U
- Status last verified
- Mar 2017
- First submitted
- 18 Jun 2016
- Last updated
- 14 Mar 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 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
- ClinicalTrials.gov ID
- NCT02809651
- Acronym / sponsor ID
- 16/015U
- Conditions
- Ischemic Stroke, Brain Tumor, Brain Surgery, Intracranial Hemorrhage, Headache, Head Trauma
- Keywords
- Infrascanner, Intracranial hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Jun 2016 (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.
The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.
Detailed description
Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).
Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke | Experimental | Device: Infrascannerpatients suffering from ischemic stroke diagnosed by clinical examination and CT-scan |
| Brain tumor | Experimental | Device: Infrascannerpatients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI |
| Brain surgery | Experimental | Device: Infrascannerpatients that have undergone brain surgery |
| Intracranial hemorrhage | Active comparator | Device: Infrascannerpatients with intracranial hemorrhage diagnosed by clinical examination and CT-scan |
| Headache | Experimental | Device: Infrascannerpatients with headache complaints and a normal CT-scan of the brain |
| Headtrauma | Experimental | Device: Infrascannerpatients with head trauma and a normal CT-scan of the brain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with ischemic stroke diagnosed by clinical examination and CT-scan
- Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI
- Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan
- Patients that have undergone brain surgery
- Patients with a normal CT-scan of the brain after head trauma
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Infrascannerbilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head. | Device | Brain surgery, Brain tumor, Headache, Headtrauma, Intracranial hemorrhage, Ischemic stroke |
Primary outcome
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
Time frame: 5 minutes
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 14 Mar 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.
Pascal Vanelderen, MD, PhD principal investigator
member of Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrascanner in people with Ischemic Stroke and Brain Tumor, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 6 inclusion and 1 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 14 Mar 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 Belgium. 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?
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard) (time frame: 5 minutes). 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 14 Mar 2017.