NCT00692744|CompletedDMC
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
FASHE
Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
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FASHE
Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
Sponsor study identifier
observational
353
1 country
2
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2008
Actual (reported)June 6, 2008
Actual (reported)October 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 2014
Actual (reported)January 2014
Actual (reported)Modified Rankin Scale score
12 months
Min Mental State Examination
12 months
Quality of LIfe, QLQ C30 questionnaire from EORTC
12 months
Self-maintaining and instrumental activities of daily living, ADL and IADL score
12 months
Hydrocephalus and risk factors
12 months
Causes of morbidity and mortality
12 months
After randomization, this group was constituted of patients treated by microsurgical clipping.
After randomization, this group was constituted of patients treated by endovascular coiling.
The randomization was ethically unsuitable because of the aneurysm predisposed to the microsurgical clipping after discussion into the neurovascular interdisciplinary team.
The randomization was ethically unsuitable because of the aneurysm morphology predisposed to the endovascular coiling after discussion into the neurovascular interdisciplinary team.
This group was constituted of patients whom no curative treatment of the aneurysm sac could not be proposed.
Primary cara clinic in differents countries of France
PROUST
Rouen, 76031, France
Rouen University Hospital
Rouen, 76031, France
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.
Proust 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.
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.
François PROUST, M.D., Ph.D.
University Hospital, Rouen
Serge BRACARD, M.D., Ph.D.
Central Hospital, Nancy, France
Guillaume PENCHET, M.D.
University Hospital, Bordeaux
Evelyne EMERY, M.D.
University Hospital, Caen
353 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2008
First Posted
June 6, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Magnesium Treating Subarachnoid Hemorrhage Vasospasm
Contact the study team to confirm eligibility.
Bernard IRTHUM, M.D.
Clermont University Hospital
Klaus MOURIER, M.D.
Centre Hospitalier Universitaire Dijon
Emmanuel GAY, M.D.
University Hospital, Grenoble
Jean-Paul LEJEUNE, M.D.
University Hospital, Lille
Isabelle PELISSOU, M.D.
Hospices Civils de Lyon
Pierre Hughes ROCHE, M.D.
University Hospital, Marseille
Thierry CIVIT, M.D.
Central Hospital, Nancy, France
Michel LONJON, M.D.
Nice University Hospital
Philippe DAVID, M.D.
Paris University Hospital
Benoit BATAILLE, M.D.
Poitiers University Hospital
Xavier MORANDI, M.D.
Rennes University Hospital
Jacques LAGUARRIGUE, M.D.
University Hospital, Toulouse
Romain BILLON-GRAND, M.D.
Besançon University Hospital
Damien BRESSON, M.D.
Paris University Hospital
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
September 3, 2014
Record last verified: 2014-09
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