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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Procedure: measuring cerebral perfusion by NIRS with ICG
    • 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)

Arms, Groups and Cohorts

  • Experimental: indocyanine green
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • with near-infrared-spectroscopy detected cerebral perfusion deficit
    • Time Frame: 15 days after ictus

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cologne
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gerrit Brinker, senior physician – University of Cologne
  • Overall Official(s)
    • Gerrit Brinker, physician, Principal Investigator, Universitiy of Cologne, Departement of General Neurosurgery

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