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

NCT ID: NCT01836848

Last Updated: 2013-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

measuring cerebral perfusion by NIRS with ICG

Intervention Type 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)

Interventions

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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)

Intervention Type PROCEDURE

Other Intervention Names

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indocyanine green NIRO-200NX C10488, Hamamatsu Photonics K.K.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Gerrit Brinker

senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerrit Brinker, physician

Role: PRINCIPAL_INVESTIGATOR

Universitiy of Cologne, Departement of General Neurosurgery

Locations

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Departement of General Neurosurgery of th University of Cologne

Cologne, , Germany

Site Status

Countries

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Germany

Facility Contacts

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André Pascal Schulte, physician

Role: primary

0049 (0)221 478 97707

Michael Reiner, physician

Role: backup

0049 (0)221 478 97710

Other Identifiers

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NCH-NIRS-001

Identifier Type: -

Identifier Source: org_study_id

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