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Clinical Trials/NCT01836848
NCT01836848
Unknown
Not Applicable

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

University of Cologne1 site in 1 country30 target enrollmentJune 2013
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ConditionsSubarachnoid Hemorrhage, AneurysmalIntracerebral Hemorrhage (ICH)Traumatic Brain Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subarachnoid Hemorrhage, Aneurysmal
Sponsor
University of Cologne
Enrollment
30
Locations
1
Primary Endpoint
with near-infrared-spectroscopy detected cerebral perfusion deficit
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 2016
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gerrit Brinker

senior physician

University of Cologne

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

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(15 days after ictus and follow up 6 month later)

Study Sites (1)

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