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

NCT01836848 | Unknown

• 1 other identifier: NCH-NIRS-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

subarachnoid hemorrhage; near-infrared-spectroscopy; indocyanine green; secondary ischemia

Outcome Measures

Primary Outcomes (1)

• with near-infrared-spectroscopy detected cerebral perfusion deficit

  15 days after ictus

Secondary Outcomes (1)

• 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 Arms (1)

indocyanine green

EXPERIMENTAL

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

measuring cerebral perfusion by NIRS with ICG PROCEDURE

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.

indocyanine green

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Departement of General Neurosurgery of th University of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cerebral Hemorrhage; Brain Injuries, Traumatic

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gerrit Brinker, physician

  Universitiy of Cologne, Departement of General Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 22, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

DE (1)