Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG

University of Cologne

Status: Unknown

Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage, Aneurysmal; Intracerebral Hemorrhage (ICH)

Treatments: Procedure: measuring cerebral perfusion by NIRS with ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT01836848

NCH-NIRS-001

Details and patient eligibility

About

The purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral perfusion.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years
• onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h
• indication for implanting a tissue oxygen and intracranial pressure probe
• A signed informed consent by the patient or legal guardian

Exclusion criteria

• Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode
• Open injuries in the area of the planned optodes
• Malignant primary disease under chemotherapy
• pregnancy
• bleeding disorder
• In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils)
• Patients with pacemakers or where no MRI compatibility is due to non- removable metal parts
• contraindications for contrast media in CT (eg, iodine allergy)
• Untreated hyperthyroidism
• End Stage Renal Disease
• severe psychomotor agitation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

indocyanine green

Experimental group

Description:

in this arm we do the Intervention 'measuring cerebral perfusion by NIRS with ICG', the pat. gets before a CT-Scan with perfusion measurement a indocyanine green bolus i.v. and a measurement of cerebral perfusion with near-infrared-spectroscopy

Treatment:

Procedure: measuring cerebral perfusion by NIRS with ICG