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Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02809651
Enrollment
89
Registered
2016-06-22
Start date
2016-08-31
Completion date
2017-02-28
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Surgery, Brain Tumor, Headache, Head Trauma, Intracranial Hemorrhage, Ischemic Stroke

Keywords

Infrascanner, Intracranial hemorrhage

Brief 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 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.

Interventions

bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frame
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)5 minutes

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026