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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
measuring cerebral perfusion by NIRS with ICG
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring subarachnoid hemorrhage, near-infrared-spectroscopy, indocyanine green, secondary ischemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of General Neurosurgery of th University of Cologne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

indocyanine green

Arm Description

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

Outcomes

Primary Outcome Measures

with near-infrared-spectroscopy detected cerebral perfusion deficit

Secondary Outcome Measures

Determining a threshold value for cerebral autoregulation measured with near-infrared-spectroscopy as a predictive value for the clinical outcome

Full Information

First Posted
April 17, 2013
Last Updated
April 17, 2013
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01836848
Brief Title
Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal, Intracerebral Hemorrhage (ICH), Traumatic Brain Injury
Keywords
subarachnoid hemorrhage, near-infrared-spectroscopy, indocyanine green, secondary ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
indocyanine green
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
measuring cerebral perfusion by NIRS with ICG
Other Intervention Name(s)
indocyanine green, NIRO-200NX C10488, Hamamatsu Photonics K.K.
Intervention Description
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)
Primary Outcome Measure Information:
Title
with near-infrared-spectroscopy detected cerebral perfusion deficit
Time Frame
15 days after ictus
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerrit Brinker, physician
Organizational Affiliation
Universitiy of Cologne, Departement of General Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of General Neurosurgery of th University of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Pascal Schulte, physician
Phone
0049 (0)221 478 97707
Email
andre.schulte@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Michael Reiner, physician
Phone
0049 (0)221 478 97710
Email
michael.reiner@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Michael Reiner, physician
First Name & Middle Initial & Last Name & Degree
André Pascal Schulte, physician
First Name & Middle Initial & Last Name & Degree
Gerrit Brinker, physician

12. IPD Sharing Statement

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

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