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

September 1, 2014 updated by: University Hospital, Rouen

Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Rouen, France, 76031
    - Rouen University Hospital
  - Rouen, France, 76031
    - PROUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary cara clinic in differents countries of France

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified Rankin Scale score Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Min Mental State Examination Time Frame: 12 months	12 months
Quality of LIfe, QLQ C30 questionnaire from EORTC Time Frame: 12 months	12 months
Self-maintaining and instrumental activities of daily living, ADL and IADL score Time Frame: 12 months	12 months
Hydrocephalus and risk factors Time Frame: 12 months	12 months
Causes of morbidity and mortality Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

Principal Investigator: François PROUST, M.D., Ph.D., Rouen University Hospital
Principal Investigator: Serge BRACARD, M.D., Ph.D., Central Hospital, Nancy, France
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., Centre Hospitalier Universitaire Dijon
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., 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., Toulouse University Hospital
Study Director: Romain BILLON-GRAND, M.D., Besançon University Hospital
Study Director: Damien BRESSON, M.D., Paris University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)