Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Not Applicable

Completed

• Conditions: Intracranial Hemorrhage; Head Trauma; Brain Tumor; Brain Surgery; Headache; Ischemic Stroke
• Interventions: Device: Infrascanner

• Registration Number: NCT02809651
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Study Timeline

• Study First Submitted: 2016-06-18
• Study First Submitted QC: 2016-06-18
• Study First Posted: 2016-06-22
• Study Start: 2016-08
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracranial hemorrhage	Infrascanner	patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan
Headtrauma	Infrascanner	patients with head trauma and a normal CT-scan of the brain
Ischemic stroke	Infrascanner	patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan
Brain tumor	Infrascanner	patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI
Brain surgery	Infrascanner	patients that have undergone brain surgery
Headache	Infrascanner	patients with headache complaints and a normal CT-scan of the brain

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium