Status unknownNCT01836848Updated Apr 22, 2013

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

An interventional study of measuring cerebral perfusion by NIRS with ICG in Subarachnoid Hemorrhage, Aneurysmal, Intracerebral Hemorrhage (ICH) and Traumatic Brain Injury, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by University of Cologne · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

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

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Keywords

subarachnoid hemorrhage
near-infrared-spectroscopy
indocyanine green
secondary ischemia

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

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

Interventions

Proceduremeasuring 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)
Also known as: indocyanine green, NIRO-200NX C10488, Hamamatsu Photonics K.K.

What researchers measure

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
Time frame: 15 days after ictus and follow up 6 month later

Study locations

1 site

Departement of General Neurosurgery of th University of Cologne
Cologne, 50937, Germany
- André Pascal Schulte, physician · Contact · andre.schulte@uk-koeln.de · 0049 (0)221 478 97707
- Michael Reiner, physician · Contact · michael.reiner@uk-koeln.de · 0049 (0)221 478 97710
- Michael Reiner, physician · Sub investigator
- André Pascal Schulte, physician · Sub investigator
- Gerrit Brinker, physician · Principal investigator

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01836848
Lead sponsor: University of Cologne
Responsible party: Gerrit Brinker (senior physician, University of Cologne) — Principal investigator
First posted: Apr 22, 2013
Start date: Jun 2013
Primary completion: Dec 2015 (estimated)
Completion: Jun 2016 (estimated)
Last update: Apr 22, 2013

Study contacts

Gerrit Brinker, physician

principal investigator · Universitiy of Cologne, Departement of General Neurosurgery

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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