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

University of Cologne30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

measuring cerebral perfusion by NIRS with ICGPROCEDURE

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Departement of General Neurosurgery of th University of Cologne

Cologne, Germany

Outcomes

Primary Outcomes

with near-infrared-spectroscopy detected cerebral perfusion deficit

Time frame: 15 days after ictus

Secondary Outcomes

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

Data from ClinicalTrials.gov

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