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Clinical Trials/NCT02809651
NCT02809651
Completed
Not Applicable

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

Ziekenhuis Oost-Limburg1 site in 1 country89 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Ziekenhuis Oost-Limburg
Enrollment
89
Locations
1
Primary Endpoint
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
February 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ziekenhuis Oost-Limburg
Responsible Party
Principal Investigator
Principal Investigator

Pascal Vanelderen

Prof. Dr.

Ziekenhuis Oost-Limburg

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

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 5 minutes

Study Sites (1)

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