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Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Primary Purpose

Ischemic Stroke, Brain Tumor, Brain Surgery

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Infrascanner
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Stroke focused on measuring Infrascanner, Intracranial hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Ischemic stroke

Brain tumor

Brain surgery

Intracranial hemorrhage

Headache

Headtrauma

Arm Description

patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan

patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI

patients that have undergone brain surgery

patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan

patients with headache complaints and a normal CT-scan of the brain

patients with head trauma and a normal CT-scan of the brain

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2016
Last Updated
March 13, 2017
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT02809651
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Brain Tumor, Brain Surgery, Intracranial Hemorrhage, Headache, Head Trauma
Keywords
Infrascanner, Intracranial hemorrhage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic stroke
Arm Type
Experimental
Arm Description
patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan
Arm Title
Brain tumor
Arm Type
Experimental
Arm Description
patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI
Arm Title
Brain surgery
Arm Type
Experimental
Arm Description
patients that have undergone brain surgery
Arm Title
Intracranial hemorrhage
Arm Type
Active Comparator
Arm Description
patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan
Arm Title
Headache
Arm Type
Experimental
Arm Description
patients with headache complaints and a normal CT-scan of the brain
Arm Title
Headtrauma
Arm Type
Experimental
Arm Description
patients with head trauma and a normal CT-scan of the brain
Intervention Type
Device
Intervention Name(s)
Infrascanner
Intervention Description
bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.
Primary Outcome Measure Information:
Title
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
Time Frame
5 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Vanelderen, MD, PhD
Organizational Affiliation
member of Staff
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

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