- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01836848
Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG
April 17, 2013 updated by: Gerrit Brinker, University of Cologne
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
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cologne, Germany, 50937
- Departement of General Neurosurgery of th University of Cologne
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Contact:
- André Pascal Schulte, physician
- Phone Number: 0049 (0)221 478 97707
- Email: andre.schulte@uk-koeln.de
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Contact:
- Michael Reiner, physician
- Phone Number: 0049 (0)221 478 97710
- Email: michael.reiner@uk-koeln.de
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Sub-Investigator:
- Michael Reiner, physician
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Sub-Investigator:
- André Pascal Schulte, physician
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Principal Investigator:
- Gerrit Brinker, physician
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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
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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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
with near-infrared-spectroscopy detected cerebral perfusion deficit
Time Frame: 15 days after ictus
|
15 days after ictus
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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15 days after ictus and follow up 6 month later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerrit Brinker, physician, Universitiy of Cologne, Departement of General Neurosurgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
June 1, 2016
Study Registration Dates
First Submitted
April 17, 2013
First Submitted That Met QC Criteria
April 17, 2013
First Posted (ESTIMATE)
April 22, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 22, 2013
Last Update Submitted That Met QC Criteria
April 17, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Brain Injuries
- Wounds and Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Subarachnoid Hemorrhage
- Cerebral Hemorrhage
Other Study ID Numbers
- NCH-NIRS-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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