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RecruitingNCT04522856Updated Apr 17, 2024

Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia

An observational study in Cerebral Ischemia, sponsored by European Society of Anaesthesiology. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by European Society of Anaesthesiology · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
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Study summary

Endovascular thrombectomy is the standard of care for acute ischaemic stroke due to large-vessel occlusion. Current guidelines for periprocedural anaesthesiological care give gross recommendations on management of stroke patients during recanalization, but lack detailed information.

To determine how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique, choice of substances, haemodynamic management, and ventilation. With a multivariate analysis, the investigators will look for the factors of anesthetic management that are independently correlated with a good or bad outcome.

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02

Conditions studied

  • Cerebral Ischemia

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Keywords

  • Endovascular thrombectomy
  • acute ischaemic stroke
  • large-vessel occlusion
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In context

Brain Ischemia

217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 203 across 72 observational studies indexed under Brain Ischemia.

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Lead sponsor

European Society of Anaesthesiology is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Study population

The target population consists of patients undergoing emergency endovascular thrombectomy for treatment of AIS-LVO. The planned minimum sample size is 5,000 patients.

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

  • Endovascular stroke treatment involving anaesthesia care

Exclusion criteria

Exclusion Criteria:

  • In-hospital onset of stroke
  • Inclusion in an interventional study concerning the anaesthesia protocol
  • Age under 18 years
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Endovascular thrombectomy

    there is only one group of the subjects that had stroke and went under thrombectomy procedure and to see how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique,choice of substances, haemodynamic management, and ventilation.

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What researchers measure

Primary outcomes

  1. Neurological outcome 90 days after the stroke

    Neurological outcome is measured using the modified Rankin Scale \[0-6\], with higher values indicating worse outcome. As a Primary Outcome Measure, the scale will be dichotomized into good (modified Rankin Scale ≤ 2) versus poor (modified Rankin Scale \> 2) outcome.

    Time frame: 90 days

Secondary outcomes

  1. Mortality

    Mortality rate 90 days after the stroke. Mortality rate is the percentage of patients that have died within 90 days following their stroke.

    Time frame: 90 days

  2. Grade of recanalization

    Recanalization is classified according to the modified Thrombolysis in Cerebral Infarction classification (mTICI) \[0 - 3\], with higher values indicating better reperfusion.

    Time frame: sixty minutes

  3. Duration

    Duration \[minutes\] from patient's arrival in angiography suite to arterial puncture for endovascular thrombectomy. Duration \[minutes\] from patient's arrival in angiography suite to arterial puncture for endovascular thrombectomy. Duration \[minutes\] from arterial puncture to end of endovascular thrombectomy.

    Time frame: 30 Minutes

  4. Proportion of patients breathing spontaneously

    Proportion of patients breathing spontaneously after thrombectomy \[Time Frame: On transfer from angiography suite after thrombectomy, which typically takes 1 hour\]. This is defined as percentage of patients that breathe spontaneously without laryngeal mask, laryngeal tube, or endotracheal tube after thrombectomy.

    Time frame: sixty minutes

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2021 (actual). Primary completion is estimated for Apr 2024, 32 months after the start.

Of 34 non-industry observational studies under Brain Ischemia, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 121. This study's planned 32 months is below that.

Counting every sponsor, half of 36 studies reached it within 72 months; a quarter within 36 and three quarters within 121.

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

Registered
Jun 15, 2020
First posted
Aug 21, 2020
StartActual
Aug 1, 2021
Primary completionEst.
Apr 30, 2024
CompletionEst.
Aug 30, 2024
Last update
Apr 17, 2024
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 Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04522856
Lead sponsor
European Society of Anaesthesiology
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Aug 1, 2021
Primary completion
Apr 30, 2024 (estimated)
Completion
Aug 30, 2024 (estimated)
Last update
Apr 17, 2024

Study contacts

Andreas Ranft, Dr.
Contact
andreas.ranft@tum.de
004989 4140 9632
Andreas Ranft, Dr.
study chair · Senior Physician-München, Germany

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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