Clinical trial NCT00692744: Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
Official title: Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysmal Subarachnoid Hemorrhage
Hydrocephalus
Cerebral Vasospasm
Keywords: Subarachnoid hemorrhage
Cerebral aneurysm
Elderly
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 353
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary cara clinic in differents countries of France

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 12 months
Secondary outcomes:
measure: Min Mental State Examination
timeFrame: 12 months
measure: Quality of LIfe, QLQ C30 questionnaire from EORTC
timeFrame: 12 months
measure: Self-maintaining and instrumental activities of daily living, ADL and IADL score
timeFrame: 12 months
measure: Hydrocephalus and risk factors
timeFrame: 12 months
measure: Causes of morbidity and mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: PROUST
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: François PROUST, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Serge BRACARD, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Guillaume PENCHET, M.D.
role: STUDY_DIRECTOR
affiliation: University Hospital, Caen
name: Evelyne EMERY, M.D.
role: STUDY_DIRECTOR
affiliation: Clermont University Hospital
name: Bernard IRTHUM, M.D.
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Klaus MOURIER, M.D.
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: Emmanuel GAY, M.D.
role: STUDY_DIRECTOR
affiliation: Lille University Hospital
name: Jean-Paul LEJEUNE, M.D.
role: STUDY_DIRECTOR
affiliation: Hospices Civils de Lyon
name: Isabelle PELISSOU, M.D.
role: STUDY_DIRECTOR
affiliation: University Hospital, Marseille
name: Pierre Hughes ROCHE, M.D.
role: STUDY_DIRECTOR
affiliation: Central Hospital, Nancy, France
name: Thierry CIVIT, M.D.
role: STUDY_DIRECTOR
affiliation: Nice University Hospital
name: Michel LONJON, M.D.
role: STUDY_DIRECTOR
affiliation: Paris University Hospital
name: Philippe DAVID, M.D.
role: STUDY_DIRECTOR
affiliation: Poitiers University Hospital
name: Benoit BATAILLE, M.D.
role: STUDY_DIRECTOR
affiliation: Rennes University Hospital
name: Xavier MORANDI, M.D.
role: STUDY_DIRECTOR
affiliation: University Hospital, Toulouse
name: Jacques LAGUARRIGUE, M.D.
role: STUDY_DIRECTOR
affiliation: Besançon University Hospital
name: Romain BILLON-GRAND, M.D.
role: STUDY_DIRECTOR
affiliation: Paris University Hospital
name: Damien BRESSON, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.