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

Completed

• Conditions: Aneurysmal Subarachnoid Hemorrhage; Hydrocephalus; Cerebral Vasospasm

• Registration Number: NCT00692744
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Study Start: 2008-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale score	12 months

Secondary Outcome Measures

Name	Time	Method
Min Mental State Examination	12 months
Causes of morbidity and mortality	12 months
Hydrocephalus and risk factors	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

Trial Locations

Locations (2)

Rouen University Hospital; 🇫🇷 Rouen, France

PROUST; 🇫🇷 Rouen, France