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

Study Overview
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Brief Summary
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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.

Official Title
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Continuous, Non-invasive Monitoring of Cerebral Oxygenation and Perfusion Using Near-infrared Spectroscopy With Indocyanine Green Perfusion Measurement in Patients With Traumatic Brain Injury, Intracerebral or Subarachnoid Hemorrhage

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

Intervention / Treatment
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* Procedure: measuring cerebral perfusion by NIRS with ICG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indocyanine green<br>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 | Procedure: measuring cerebral perfusion by NIRS with ICG<br>* application of a bolus of 5mg indocyanine green (ICG) in 3ml saline 0,9% i.v. in 1 second and measuring the ICG turnover with the near-infrared-spectroscopy (NIRS)<br>* Other names: NIRO-200NX C10488, Hamamatsu Photonics K.K.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| with near-infrared-spectroscopy detected cerebral perfusion deficit |  | 15 days after ictus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining a threshold value for cerebral autoregulation measured with near-infrared-spectroscopy as a predictive value for the clinical outcome |  | 15 days after ictus and follow up 6 month later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subarachnoid hemorrhage, near-infrared-spectroscopy, indocyanine green, secondary ischemia