Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809651
• Other study ID #: 16/015U
• Status: Completed
• Phase: N/A
• First received: June 18, 2016
• Last updated: March 13, 2017
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Brain Surgery
• Brain Tumor
• Craniocerebral Trauma
• Head Trauma
• Headache
• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Ischemic Stroke

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)		5 minutes