Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) (FASHE)
|ClinicalTrials.gov Identifier: NCT00692744|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 3, 2014
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|
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 Type :||Observational|
|Actual Enrollment :||353 participants|
|Official Title:||Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.|
|Study Start Date :||October 2008|
|Primary Completion Date :||January 2014|
|Study Completion Date :||January 2014|
After randomization, this group was constituted of patients treated by microsurgical clipping.
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.
- Modified Rankin Scale score [ Time Frame: 12 months ]
- 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 ]
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692744
|Rouen, France, 76031|
|Rouen University Hospital|
|Rouen, France, 76031|
|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.||Lyon University Hospital|
|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|