Hydrocephalus Clinical Trial
Official title:
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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