Subarachnoid Hemorrhage, AneurysmalNCT01836848
Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG
A study testing measuring cerebral perfusion by NIRS with ICG in people with Subarachnoid Hemorrhage, Aneurysmal and Intracerebral Hemorrhage (ICH), run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Intracerebral Hemorrhage (ICH), Traumatic Brain Injury
- What is being tested?
- measuring cerebral perfusion by NIRS with ICG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Departement of General Neurosurgery of th University of Cologne
Cologne, 50937
André Pascal Schulte, physician, 0049 (0)221 478 97707, andre.schulte@uk-koeln.de
Michael Reiner, physician, 0049 (0)221 478 97710, michael.reiner@uk-koeln.de
About this study
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
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
- Being tested
- measuring cerebral perfusion by NIRS with ICG
- Keywords
- subarachnoid hemorrhage, near-infrared-spectroscopy, indocyanine green, secondary ischemia
- Medical subject headings
- Subarachnoid Hemorrhage, Cerebral Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring cerebral perfusion by NIRS with ICGProcedure or surgery
Also called indocyanine green, NIRO-200NX C10488, Hamamatsu Photonics K.K.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: measuring cerebral perfusion by NIRS with ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
with near-infrared-spectroscopy detected cerebral perfusion deficit
Measured: 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
Measured: 15 days after ictus and follow up 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerrit Brinker, University of Cologne
- Investigators
- Gerrit Brinker, physician, Principal investigator, Universitiy of Cologne, Departement of General Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836848
- Sponsor's protocol ID
- NCH-NIRS-001
- Status last verified
- Apr 2013
- First submitted
- 17 Apr 2013
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01836848
- Acronym / sponsor ID
- NCH-NIRS-001
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal, Intracerebral Hemorrhage (ICH), Traumatic Brain Injury
- Keywords
- subarachnoid hemorrhage, near-infrared-spectroscopy, indocyanine green, secondary ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| indocyanine green | Experimental | Procedure: measuring cerebral perfusion by NIRS with ICGin 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measuring cerebral perfusion by NIRS with ICGAlso: indocyanine green, NIRO-200NX C10488, Hamamatsu Photonics K.K.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) | Procedure or surgery | indocyanine green |
Primary outcome
with near-infrared-spectroscopy detected cerebral perfusion deficit
Time frame: 15 days after ictus
1 secondary outcome
Determining a threshold value for cerebral autoregulation measured with near-infrared-spectroscopy as a predictive value for the clinical outcome
Time frame: 15 days after ictus and follow up 6 month later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Departement of General Neurosurgery of th University of Cologne
Cologne, Germany
Gerrit Brinker, physician principal investigator
Universitiy of Cologne, Departement of General Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measuring cerebral perfusion by NIRS with ICG in people with Subarachnoid Hemorrhage, Aneurysmal and Intracerebral Hemorrhage (ICH), run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
with near-infrared-spectroscopy detected cerebral perfusion deficit (time frame: 15 days after ictus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.