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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by University of Cologne
Sponsor:
Collaborator:
University of Cologne, Departement General Neurosurgery
Information provided by (Responsible Party):
Gerrit Brinker, University of Cologne
ClinicalTrials.gov Identifier:
NCT01836848
First received: April 17, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Subarachnoid Hemorrhage, Aneurysmal
Intracerebral Hemorrhage (ICH)
Traumatic Brain Injury
Procedure: measuring cerebral perfusion by NIRS with ICG

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • with near-infrared-spectroscopy detected cerebral perfusion deficit [ Time Frame: 15 days after ictus ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)
Other Names:
  • indocyanine green
  • NIRO-200NX C10488, Hamamatsu Photonics K.K.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836848

Locations
Germany
Departement of General Neurosurgery of th University of Cologne Not yet recruiting
Cologne, Germany, 50937
Contact: André Pascal Schulte, physician    0049 (0)221 478 97707    andre.schulte@uk-koeln.de   
Contact: Michael Reiner, physician    0049 (0)221 478 97710    michael.reiner@uk-koeln.de   
Sub-Investigator: Michael Reiner, physician         
Sub-Investigator: André Pascal Schulte, physician         
Principal Investigator: Gerrit Brinker, physician         
Sponsors and Collaborators
University of Cologne
University of Cologne, Departement General Neurosurgery
Investigators
Principal Investigator: Gerrit Brinker, physician Universitiy of Cologne, Departement of General Neurosurgery
  More Information

No publications provided

Responsible Party: Gerrit Brinker, senior physician, University of Cologne
ClinicalTrials.gov Identifier: NCT01836848     History of Changes
Other Study ID Numbers: NCH-NIRS-001
Study First Received: April 17, 2013
Last Updated: April 17, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
subarachnoid hemorrhage
near-infrared-spectroscopy
indocyanine green
secondary ischemia

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Intracranial Hemorrhages
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014