Cerebral IschemiaNCT04522856
Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia
An observational study of Cerebral Ischemia, run by European Society of Anaesthesiology at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Ischemia
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 30 Aug 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Endovascular stroke treatment involving anaesthesia care
Who cannot join
- In-hospital onset of stroke
- Inclusion in an interventional study concerning the anaesthesia protocol
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
see brief summary
- Conditions
- Cerebral Ischemia
- Keywords
- Endovascular thrombectomy, acute ischaemic stroke, large-vessel occlusion
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
Mortality
Mortality rate 90 days after the stroke. Mortality rate is the percentage of patients that have died within 90 days following their stroke.
Measured: 90 days
Grade of recanalization
Recanalization is classified according to the modified Thrombolysis in Cerebral Infarction classification (mTICI) [0 - 3], with higher values indicating better reperfusion.
Measured: sixty minutes
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.
Measured: 30 Minutes
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.
Measured: sixty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Aug 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral IschemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Ranft, Dr., Study chair, Senior Physician-München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522856
- Sponsor's protocol ID
- ARCTIC-I
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia
- ClinicalTrials.gov ID
- NCT04522856
- Acronym / sponsor ID
- ARCTIC-I
- Conditions
- Cerebral Ischemia
- Keywords
- Endovascular thrombectomy, acute ischaemic stroke, large-vessel occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Aug 2020 (actual)
- 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.
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.
Detailed description
see brief summary
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Endovascular stroke treatment involving anaesthesia care
Key exclusion criteria (3 listed)
- In-hospital onset of stroke
- Inclusion in an interventional study concerning the anaesthesia protocol
- Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological outcome 90 days after the stroke
Time frame: 90 days
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.
4 secondary outcomes
Mortality
Time frame: 90 days
Grade of recanalization
Time frame: sixty minutes
Duration
Time frame: 30 Minutes
Proportion of patients breathing spontaneously
Time frame: sixty minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Andreas Ranft, Dr. study chair
Senior Physician-München, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Ischemia, run by European Society of Anaesthesiology 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 1 inclusion and 3 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 17 Apr 2024. 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?
Contact Andreas Ranft, Dr. (004989 4140 9632, andreas.ranft@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome 90 days after the stroke (time frame: 90 days). 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 17 Apr 2024.