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

U

University Hospital, Rouen

Status

Completed

Conditions

Hydrocephalus
Aneurysmal Subarachnoid Hemorrhage
Cerebral Vasospasm

Study type

Observational

Funder types

Other

Identifiers

NCT00692744
2007/042/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment

353 patients

Sex

All

Ages

70 to 90 years old

Volunteers

No 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

Trial design

353 participants in 5 patient groups

Randomized microsurgical
Description:
After randomization, this group was constituted of patients treated by microsurgical clipping.
Randomized endovascular
Description:
After randomization, this group was constituted of patients treated by endovascular coiling.
Prospective observational microsurgical
Description:
The randomization was ethically unsuitable because of the aneurysm predisposed to the microsurgical clipping after discussion into the neurovascular interdisciplinary team.
Prospective observational endovascular
Description:
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
Description:
This group was constituted of patients whom no curative treatment of the aneurysm sac could not be proposed.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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