Ischemic StrokeNCT01990014
Craniectomy Protocol
An observational study of Ischemic Stroke and Decompressive Craniectomy, run by Nantes University Hospital at 4 sites in France.
Trial summary
The objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Decompressive Craniectomy
- How many people
- 62 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2011to Jul 2013
- 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: Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.
Who may be able to join
- Age> = 18 years
- Having presented an ischemic stroke involving the sylvian area
- Having received decompressive craniectomy in acute ischemic stroke
- Time between stroke and the inclusion of at least 24 months
- Signed informed consent
- Patient affiliated to a social security system
Who cannot join
- Patients with a Rankin score before stroke than or equal to 3
- Stroke in multiple territories (contralateral carotid and / or vertebrobasilar) associated with stroke in the acute phase describing which in the opinion of the investigator significantly influence the long-term functional prognosis
- Cognitive deterioration or severe aphasia making it impossible to fill out questionnaires
- Minors
- Major under curators
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Angers
Angers
CHU de Brest
Brest
CH R U Pontchaillou
Rennes
CHU Bretonneau
Tours
About this study
Official title: Multicenter Clinical Study Evaluating the Functional Prognosis and Quality of Life at Least 2 Years in Patients Treated With Decompressive Craniectomy for Malignant Sylvian Ischemic Stroke
The objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. Will be measured the quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.
- Conditions
- Ischemic Stroke, Decompressive Craniectomy
- Medical subject headings
- Ischemic 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 |
|---|---|---|
| craniectomy | Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.
Measured: at least two years
Secondary outcomes (7)
To evaluate the quality of life in the physical and psychosocial domains
Measured: at least two years
To evaluate the evolution of functional disability
Measured: At 3 months, 12 months and 24 months.
To evaluate the life satisfaction
Measured: at least two years
To assess the rate of recovery work
Measured: at least two years
To evaluate the retrospective review of patients achieving craniectomy
Measured: at least two years
To determine the prognostic factors that influence the level of handicap and quality of life in the long term.
Measured: at least two years
To evaluate the quality of life and level of long-term care accompanying persons caring for the near a victim of malignant sylvian ischemic stroke who received a decompressive craniotomy.
Measured: at least two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SÉVIN ALLOUET Mathieu, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990014
- Sponsor's protocol ID
- BRD/10/08-I
- Status last verified
- Sep 2021
- First submitted
- 25 Oct 2013
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study Evaluating the Functional Prognosis and Quality of Life at Least 2 Years in Patients Treated With Decompressive Craniectomy for Malignant Sylvian Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01990014
- Acronym / sponsor ID
- BRD/10/08-I
- Conditions
- Ischemic Stroke, Decompressive Craniectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Nov 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 objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. Will be measured the quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| craniectomy | – | –Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.
Key inclusion criteria (6 listed)
- Age> = 18 years
- Having presented an ischemic stroke involving the sylvian area
- Having received decompressive craniectomy in acute ischemic stroke
- Time between stroke and the inclusion of at least 24 months
- Signed informed consent
Key exclusion criteria (5 listed)
- Patients with a Rankin score before stroke than or equal to 3
- Stroke in multiple territories (contralateral carotid and / or vertebrobasilar) associated with stroke in the acute phase describing which in the opinion of the investigator significantly influence the long-term functional prognosis
- Cognitive deterioration or severe aphasia making it impossible to fill out questionnaires
- Minors
- Major under curators
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
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.
Time frame: at least two years
7 secondary outcomes
To evaluate the quality of life in the physical and psychosocial domains
Time frame: at least two years
To evaluate the evolution of functional disability
Time frame: At 3 months, 12 months and 24 months.
To evaluate the life satisfaction
Time frame: at least two years
To assess the rate of recovery work
Time frame: at least two years
To evaluate the retrospective review of patients achieving craniectomy
Time frame: at least two years
To determine the prognostic factors that influence the level of handicap and quality of life in the long term.
Time frame: at least two years
To evaluate the quality of life and level of long-term care accompanying persons caring for the near a victim of malignant sylvian ischemic stroke who received a decompressive craniotomy.
Time frame: at least two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
SÉVIN ALLOUET Mathieu, Dr principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Decompressive Craniectomy, run by Nantes University Hospital at 4 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy. (time frame: at least two years). 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 10 Sep 2021.