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Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) (FASHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692744
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 3, 2014
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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.

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.

Condition or disease
Aneurysmal Subarachnoid Hemorrhage Hydrocephalus Cerebral Vasospasm

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.

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Study Type : Observational
Actual Enrollment : 353 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
Study Start Date : October 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.

Primary Outcome Measures :
  1. Modified Rankin Scale score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Min Mental State Examination [ Time Frame: 12 months ]
  2. Quality of LIfe, QLQ C30 questionnaire from EORTC [ Time Frame: 12 months ]
  3. Self-maintaining and instrumental activities of daily living, ADL and IADL score [ Time Frame: 12 months ]
  4. Hydrocephalus and risk factors [ Time Frame: 12 months ]
  5. Causes of morbidity and mortality [ Time Frame: 12 months ]

Biospecimen Retention:   None Retained
2 randomized arms (clipping and coiling) and 3 prospective observational arms (clipping, coiling, conservative) For the randomized arms, we anticipated 20 patients in each arm.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary cara clinic in differents countries of France

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients in grade V of WFNS scale
  • Subarachnoid hemorrhage without cerebral aneurysm
  • Patients with cerebral dementia, neurologic or psychiatric antecedents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692744

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Rouen, France, 76031
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
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Principal Investigator: François PROUST, M.D., Ph.D. Rouen University Hospital
Principal Investigator: Serge BRACARD, M.D., Ph.D. Nancy University Hospital
Study Director: Guillaume PENCHET, M.D. University Hospital, Bordeaux
Study Director: Evelyne EMERY, M.D. University Hospital, Caen
Study Director: Bernard IRTHUM, M.D. Clermont University Hospital
Study Director: Klaus MOURIER, M.D. Dijon University Hospital
Study Director: Emmanuel GAY, M.D. University Hospital, Grenoble
Study Director: Jean-Paul LEJEUNE, M.D. Lille University Hospital
Study Director: Isabelle PELISSOU, M.D. Hospices Civils de Lyon
Study Director: Pierre Hughes ROCHE, M.D. Marseille University Hospital
Study Director: Thierry CIVIT, M.D. Nancy University Hospital
Study Director: Michel LONJON, M.D. Nice University Hospital
Study Director: Philippe DAVID, M.D. Paris University Hospital
Study Director: Benoit BATAILLE, M.D. Poitiers University Hospital
Study Director: Xavier MORANDI, M.D. Rennes University Hospital
Study Director: Jacques LAGUARRIGUE, M.D. Toulouse University Hospital
Study Director: Romain BILLON-GRAND, M.D. Besançon University Hospital
Study Director: Damien BRESSON, M.D. Paris University Hospital
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Responsible Party: University Hospital, Rouen Identifier: NCT00692744    
Other Study ID Numbers: 2007/042/HP
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Keywords provided by University Hospital, Rouen:
Subarachnoid hemorrhage
Cerebral aneurysm
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases