Aneurysmal Subarachnoid HemorrhageFASHENCT00692744
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
An observational study of Aneurysmal Subarachnoid Hemorrhage and Hydrocephalus, run by University Hospital, Rouen at 2 sites in France.
Trial summary
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Hydrocephalus, Cerebral Vasospasm
- How many people
- 353 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2008to Jan 2014
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Primary cara clinic in differents countries of France
Who may be able to join
- 70 years old and more
- Subarachnoid hemorrhage in grade I-IV of WFNS scale
- Ruptured cerebral aneurysm diagnosed on multislice computed tomography angiography or cerebral angiography
- treatment of subarachnoid hemorrhage
Who cannot join
- Patients in grade V of WFNS scale
- Subarachnoid hemorrhage without cerebral aneurysm
- Patients with cerebral dementia, neurologic or psychiatric antecedents
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life.
In this age bracket, the single randomized which compared endovascular coiling to microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased after coiling. Moreover, some prospectives studies about endovascular coiling described favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a procedural complication rate in 13% to 19%. From prospectives series, the proportion of favorable outcome after microsurgical clipping was estimated around 66% but the procedural complications are few reported. The outcome for patients treated conservatively was catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of patients.
Read more
The study hypothesis is that, in this age class, no difference exists between the 2 obliteration procedures.
An accurate evaluation of result in term of functional disability, quality of life and prognosis predictive factors seems a judicious question.
Read the detailed description
The aim of our study was to determine a significant difference in terms of functional disability between microsurgical clipping and endovascular coiling in the elderly population.
Randomized multicenter trial: 2 randomized arms (clipping and coiling) plus 3 observational prospective arms (clipping, coiling, conservative).
Inclusion time: 48 months. Follow up: 12 months. Monitoring: 6 months. Duration of the trial: 66 months. Major end point: proportion of patients with unfavourable outcome at 12 months (mRS > 2).
Secondary end point: Quality of life at 12 months (EORTC scale), causes of morbidity (mRS > 2) and mortality, Dysautonomia according to the ADL and IADL scales.
- Keywords
- Subarachnoid hemorrhage, Cerebral aneurysm, Elderly
- Medical subject headings
- Subarachnoid Hemorrhage, Hydrocephalus, Vasospasm, Intracranial, Intracranial Aneurysm
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 |
|---|---|---|
| Randomized microsurgical | After randomization, this group was constituted of patients treated by microsurgical clipping. | |
| Randomized endovascular | After randomization, this group was constituted of patients treated by endovascular coiling. | |
| Prospective observational microsurgical | The randomization was ethically unsuitable because of the aneurysm predisposed to the microsurgical clipping after discussion into the neurovascular interdisciplinary team. | |
| Prospective observational endovascular | The randomization was ethically unsuitable because of the aneurysm morphology predisposed to the endovascular coiling after discussion into the neurovascular interdisciplinary team. | |
| Prospective observational conservative | This group was constituted of patients whom no curative treatment of the aneurysm sac could not be proposed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale score
Measured: 12 months
Secondary outcomes (5)
Min Mental State Examination
Measured: 12 months
Quality of LIfe, QLQ C30 questionnaire from EORTC
Measured: 12 months
Self-maintaining and instrumental activities of daily living, ADL and IADL score
Measured: 12 months
Hydrocephalus and risk factors
Measured: 12 months
Causes of morbidity and mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François PROUST, M.D., Ph.D., Principal investigator, University Hospital, RouenSerge BRACARD, M.D., Ph.D., Principal investigator, Central Hospital, Nancy, FranceGuillaume PENCHET, M.D., Study director, University Hospital, BordeauxEvelyne EMERY, M.D., Study director, University Hospital, CaenBernard IRTHUM, M.D., Study director, Clermont University HospitalKlaus MOURIER, M.D., Study director, Centre Hospitalier Universitaire DijonEmmanuel GAY, M.D., Study director, University Hospital, GrenobleJean-Paul LEJEUNE, M.D., Study director, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692744
- Sponsor's protocol ID
- 2007/042/HP
- Acronym
- FASHE
- Status last verified
- Sep 2014
- First submitted
- 3 Jun 2008
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Proust F, Gerardin E, Derrey S, Lesveque S, Ramos S, Langlois O, Tollard E, Benichou J, Chassagne P, Clavier E, Freger P. Interdisciplinary treatment of ruptured cerebral aneurysms in elderly patients. J Neurosurg. 2010 Jun;112(6):1200-7. doi: 10.3171/2009.10.JNS08754.
PubMed 19961311Proust F, Bracard S, Thines L, Leclerc X, Penchet G, Berge J, Vignes JR, Irthum B, Gabrillargues J, Chazal J, Bataille B, Drouinau J, Mourier K, Ricolfi F, Gay E, Bessou P, Lonjon M, Sedat J, David P, Lajaunias P, Morandi X, Gauvrit JY, Pelissou I, Turjman F, Roche PH, Dufour H, Levrier O, Emery E, Courtheoux P, Laguarrigue J, Cognard C, Civit T, Lejeune JP. [Aneurismal subarachnoid hemorrhage in the elderly subject. Should this patient participate in a randomized clinical trial?]. Neurochirurgie. 2010 Feb;56(1):67-72. doi: 10.1016/j.neuchi.2009.11.002. Epub 2010 Jan 8. No abstract available. French.
PubMed 20060549
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
- ClinicalTrials.gov ID
- NCT00692744
- Acronym / sponsor ID
- FASHE / 2007/042/HP
- Keywords
- Subarachnoid hemorrhage, Cerebral aneurysm, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jun 2008 (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.
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life.
In this age bracket, the single randomized which compared endovascular coiling to microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased after coiling. Moreover, some prospectives studies about endovascular coiling described favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a procedural complication rate in 13% to 19%. From prospectives series, the proportion of favorable outcome after microsurgical clipping was estimated around 66% but the procedural complications are few reported. The outcome for patients treated conservatively was catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of patients.
The study hypothesis is that, in this age class, no difference exists between the 2 obliteration procedures.
An accurate evaluation of result in term of functional disability, quality of life and prognosis predictive factors seems a judicious question.
Detailed description
The aim of our study was to determine a significant difference in terms of functional disability between microsurgical clipping and endovascular coiling in the elderly population.
Randomized multicenter trial: 2 randomized arms (clipping and coiling) plus 3 observational prospective arms (clipping, coiling, conservative).
Inclusion time: 48 months. Follow up: 12 months. Monitoring: 6 months. Duration of the trial: 66 months. Major end point: proportion of patients with unfavourable outcome at 12 months (mRS > 2).
Secondary end point: Quality of life at 12 months (EORTC scale), causes of morbidity (mRS > 2) and mortality, Dysautonomia according to the ADL and IADL scales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Randomized microsurgical | – | –After randomization, this group was constituted of patients treated by microsurgical clipping. |
| Randomized endovascular | – | –After randomization, this group was constituted of patients treated by endovascular coiling. |
| Prospective observational microsurgical | – | –The randomization was ethically unsuitable because of the aneurysm predisposed to the microsurgical clipping after discussion into the neurovascular interdisciplinary team. |
| Prospective observational endovascular | – | –The randomization was ethically unsuitable because of the aneurysm morphology predisposed to the endovascular coiling after discussion into the neurovascular interdisciplinary team. |
| Prospective observational conservative | – | –This group was constituted of patients whom no curative treatment of the aneurysm sac could not be proposed. |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Primary cara clinic in differents countries of France
Key inclusion criteria (4 listed)
- 70 years old and more
- Subarachnoid hemorrhage in grade I-IV of WFNS scale
- Ruptured cerebral aneurysm diagnosed on multislice computed tomography angiography or cerebral angiography
- treatment of subarachnoid hemorrhage
Key exclusion criteria (3 listed)
- Patients in grade V of WFNS scale
- Subarachnoid hemorrhage without cerebral aneurysm
- Patients with cerebral dementia, neurologic or psychiatric antecedents
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
Modified Rankin Scale score
Time frame: 12 months
5 secondary outcomes
Min Mental State Examination
Time frame: 12 months
Quality of LIfe, QLQ C30 questionnaire from EORTC
Time frame: 12 months
Self-maintaining and instrumental activities of daily living, ADL and IADL score
Time frame: 12 months
Hydrocephalus and risk factors
Time frame: 12 months
Causes of morbidity and mortality
Time frame: 12 months
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 3 Sep 2014.
- Background: PubMed 19961311Proust F, Gerardin E, Derrey S, Lesveque S, Ramos S, Langlois O, Tollard E, Benichou J, Chassagne P, Clavier E, Freger P. Interdisciplinary treatment of ruptured cerebral aneurysms in elderly patients. J Neurosurg. 2010 Jun;112(6):1200-7. doi: 10.3171/2009.10.JNS08754.
- Background: PubMed 20060549Proust F, Bracard S, Thines L, Leclerc X, Penchet G, Berge J, Vignes JR, Irthum B, Gabrillargues J, Chazal J, Bataille B, Drouinau J, Mourier K, Ricolfi F, Gay E, Bessou P, Lonjon M, Sedat J, David P, Lajaunias P, Morandi X, Gauvrit JY, Pelissou I, Turjman F, Roche PH, Dufour H, Levrier O, Emery E, Courtheoux P, Laguarrigue J, Cognard C, Civit T, Lejeune JP. [Aneurismal subarachnoid hemorrhage in the elderly subject. Should this patient participate in a randomized clinical trial?]. Neurochirurgie. 2010 Feb;56(1):67-72. doi: 10.1016/j.neuchi.2009.11.002. Epub 2010 Jan 8. No abstract available. French.
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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.
François PROUST, M.D., Ph.D. principal investigator
University Hospital, Rouen
Serge BRACARD, M.D., Ph.D. principal investigator
Central Hospital, Nancy, France
Guillaume PENCHET, M.D. study director
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage and Hydrocephalus, run by University Hospital, Rouen at 2 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 4 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: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Modified Rankin Scale score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692744, which also lists 2 linked publications.
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 3 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.