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

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ClinicalTrials.gov Identifier: NCT01836848
Recruitment Status : Unknown
Verified April 2013 by Gerrit Brinker, University of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Subarachnoid Hemorrhage, Aneurysmal Intracerebral Hemorrhage (ICH) Traumatic Brain Injury Procedure: measuring cerebral perfusion by NIRS with ICG

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. with near-infrared-spectroscopy detected cerebral perfusion deficit [ Time Frame: 15 days after ictus ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Gerrit Brinker, physician Universitiy of Cologne, Departement of General Neurosurgery
More Information

Responsible Party: Gerrit Brinker, senior physician, University of Cologne
ClinicalTrials.gov Identifier: NCT01836848     History of Changes
Other Study ID Numbers: NCH-NIRS-001
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013

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

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