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

Not Applicable

• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Intracerebral Hemorrhage (ICH); Traumatic Brain Injury
• Interventions: Procedure: measuring cerebral perfusion by NIRS with ICG

• Registration Number: NCT01836848
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Last Update Submitted: 2013-04-17
• Study First Posted: 2013-04-22
• Last Update Posted: 2013-04-22
• Study Start: 2013-06
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
indocyanine green	measuring cerebral perfusion by NIRS with ICG	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

Primary Outcome Measures

Name	Time	Method
with near-infrared-spectroscopy detected cerebral perfusion deficit	15 days after ictus

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Departement of General Neurosurgery of th University of Cologne; 🇩🇪 Cologne, Germany