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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00692744

Acronym

FASHE

Enrollment

353

Registered

2008-06-06

Start date

2008-10-31

Completion date

2014-01-31

Last updated

2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm, Hydrocephalus

Keywords

Subarachnoid hemorrhage, Cerebral aneurysm, Elderly

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

70 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Modified Rankin Scale score	12 months

Secondary

Measure	Time frame
Hydrocephalus and risk factors	12 months
Causes of morbidity and mortality	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

Countries

France

Outcome results