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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary cara clinic in differents countries of France
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| Name | Affiliation | Role |
|---|---|---|
| François PROUST, M.D., Ph.D. | University Hospital, Rouen | Principal Investigator |
| Serge BRACARD, M.D., Ph.D. | Central Hospital, Nancy, France | Principal Investigator |
| 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. | Centre Hospitalier Universitaire Dijon | Study Director |
| Emmanuel GAY, M.D. | University Hospital, Grenoble | Study Director |
| Jean-Paul LEJEUNE, M.D. | University Hospital, Lille | Study Director |
| Isabelle PELISSOU, M.D. | Hospices Civils de Lyon | Study Director |
| Pierre Hughes ROCHE, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PROUST | Rouen | 76031 | France | |||
| Rouen University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19961311 | Background | 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. | |
| 20060549 | Background | 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. |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D006849 | Hydrocephalus |
| D020301 | Vasospasm, Intracranial |
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
| 12 months |
| Hydrocephalus and risk factors | 12 months |
| Causes of morbidity and mortality | 12 months |
| University Hospital, Marseille |
| Study Director |
| Thierry CIVIT, M.D. | Central Hospital, Nancy, France | 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. | University Hospital, Toulouse | Study Director |
| Romain BILLON-GRAND, M.D. | Besançon University Hospital | Study Director |
| Damien BRESSON, M.D. | Paris University Hospital | Study Director |
| Rouen |
| 76031 |
| France |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020765 | Intracranial Arterial Diseases |
| D000783 | Aneurysm |