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Status unknownNCT03367975NIRS_ICGUpdated Dec 11, 2017

NIRS Monitoring During Intracranial Interventions

An observational study in Subarachnoid Hemorrhage and Intracranial Arteriovenous Malformation, sponsored by University Hospital, Bonn. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-11.

Sponsored by University Hospital, Bonn · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 37 studies in Subarachnoid Hemorrhage with a site in Germany — 2 open to participants now, 3 under way, none of them phase 3. Subarachnoid Hemorrhage · Germany.

Planned enrollment
16th of 16
12 · median 100
Started
2014
with 3 others
Observational
16 of 37
2 open now
Registered
19th of 37
by date
Lead sponsor
4 of 37
University Hospital, Bonn

Among the 37 studies in Subarachnoid Hemorrhage with a site in Germany, this one is the 16th largest by planned enrollment of the 16 observational ones that give a count, is one of 4 that started in 2014, is one of 16 observational ones, and was the 19th registered.

Subarachnoid Hemorrhage

510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.

Browse Subarachnoid Hemorrhage studies →

Open to participants now

2 of the 37 studies in Subarachnoid Hemorrhage with a site in Germany are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during intracranial interventions. However, it yields artificial results when the dye indocyanine green (ICG) is applied, which is routinely done for intraoperative angiography.

The investigators examine, to what extent and which duration NIRS is disturbed following ICG application.

03

Conditions studied

  • Subarachnoid Hemorrhage
  • Intracranial Arteriovenous Malformation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing cerebral aneurysm clipping or av-malformation removal

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients scheduled for aneurysm clipping or av-malformation removal

Exclusion criteria

Exclusion Criteria:

  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (estimated)
Patient registry
No

Interventions

  • Othernear infrared spectroscopy
06

What researchers measure

Primary outcomes

  1. amount of rSO2 - change [%] induced by ICG-application

    Cerebral oxygenation (rSO2) may be quantified using NIRS. The dye ICG, that is used intraoperatively, affects NIRS, since it changes rSO2 without modifying cerebral oxygenation. The amount, by which rSO2 is altered will be assessed

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn
    Bonn, 53105, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Jan 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2014
First posted
Dec 11, 2017
Start
Mar 2014
Primary completionEst.
Jan 2018
CompletionEst.
Mar 2018
Last update
Dec 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03367975
Responsible party
Martin Soehle (Consultant, University Hospital, Bonn) — Principal investigator
First posted
Dec 11, 2017
Start date
Mar 2014
Primary completion
Jan 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
Dec 11, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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