NCT00692744

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
• Phase: —
• Study type: Observational
• Enrollment: 353 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 70 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aneurysmal Subarachnoid Hemorrhage
• Hydrocephalus
• Cerebral Vasospasm

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2008-06-06
• Last updated: 2014-09-03

Locations

2 sites across 1 country: France