Clinical trial NCT02809651: Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
Official title: A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Brain Tumor
Brain Surgery
Intracranial Hemorrhage
Headache
Head Trauma
Keywords: Infrascanner
Intracranial hemorrhage
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: member of Staff
name: Pascal Vanelderen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: