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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01836848
• Other study ID #: NCH-NIRS-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 17, 2013
• Last updated: April 17, 2013
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: April 2013
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage (ICH)
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal
• Traumatic Brain Injury

Intervention

Procedure:
• measuring 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)

Locations

Country	Name	City	State
Germany	Departement of General Neurosurgery of th University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	with near-infrared-spectroscopy detected cerebral perfusion deficit		15 days after ictus	No
Secondary	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	No