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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01836848

Enrollment

Registered

2013-04-22

Start date

2013-06-30

Completion date

2016-06-30

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
with near-infrared-spectroscopy detected cerebral perfusion deficit	15 days after ictus

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026