Acute StrokeAMASNCT02895776
Risk Factors of Conversion From Local to General Sedation in Endovascular Stroke Therapy
An observational study of Acute Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2015to Jan 2017
- 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: Endovascular Acute Stroke Therapy scheduled to be performed with local sedation and either performed under General Anesthesia (case), either actually performed under conscious sedation (control). Endovascular Acute Stroke Therapy scheduled to be performed with conscious sedation and performed under General Anesthesia 3 control patients will be included per case, and matched with the moment of procedure (term of the year).
Who may be able to join
- patients undergoing thrombectomy for ischemic stroke
- age ≥ 18 years old
Who cannot join
- patient already under general anesthesia
- general sedation required
- haemorrhagic softening diagnosed before the beginning of procedure
- patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Search for Risk Factors of Conversion From Local to General Sedation in Emergency Endovascular Therapy for Acute Stroke
Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation.
The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year.
We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
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 |
|---|---|---|
| General Sedation | Case patients: Endovascular Acute Stroke Therapy scheduled to be performed under local sedation and finally performed under General anesthesia | |
| local sedation | Control patients: Endovascular Acute Stroke Therapy scheduled to be performed, and actually performed under conscious Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors associated with a conversion from conscious sedation to general anesthesia
recording of the procedures during anesthesia
Measured: during therapy (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start22 Dec 2015
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895776
- Sponsor's protocol ID
- GTR_2015_23
- Acronym
- AMAS
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for Risk Factors of Conversion From Local to General Sedation in Emergency Endovascular Therapy for Acute Stroke
- ClinicalTrials.gov ID
- NCT02895776
- Acronym / sponsor ID
- AMAS / GTR_2015_23
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 Sep 2016 (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.
Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation.
The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year.
We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Sedation | – | –Case patients: Endovascular Acute Stroke Therapy scheduled to be performed under local sedation and finally performed under General anesthesia |
| local sedation | – | –Control patients: Endovascular Acute Stroke Therapy scheduled to be performed, and actually performed under conscious Sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Endovascular Acute Stroke Therapy scheduled to be performed with local sedation and either performed under General Anesthesia (case), either actually performed under conscious sedation (control). Endovascular Acute Stroke Therapy scheduled to be performed with conscious sedation and performed under General Anesthesia 3 control patients will be included per case, and matched with the moment of procedure (term of the year).
Key inclusion criteria (2 listed)
- patients undergoing thrombectomy for ischemic stroke
- age ≥ 18 years old
Key exclusion criteria (4 listed)
- patient already under general anesthesia
- general sedation required
- haemorrhagic softening diagnosed before the beginning of procedure
- patient refusal to participate in the study
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
factors associated with a conversion from conscious sedation to general anesthesia
Time frame: during therapy (day 1)
recording of the procedures during anesthesia
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Aug 2018. 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 France. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
factors associated with a conversion from conscious sedation to general anesthesia (time frame: during therapy (day 1)). 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 9 Aug 2018.