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Stroke Interventions in Clinical Trials
Printable Version
FASHE
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage



Principal Investigator
François H Proust, M.D., Ph.D. and Serge Bracard, M.D., Ph.D.

PI Address
François H Proust, M.D., Ph.D.
Rouen University Hospital
ROUEN, France, 76031

33-23-288-8042

Sponsor



Study Size Planned:390
Max Age:90
Min Age:70
Follow-up Duration:12 Months
ISRCTN#NCT00692744
Status:
This study is ongoing, but not recruiting participants.

Purpose:
To determine if difference exists between the 2 obliteration procedures (endovascular coiling to microsurgical clipping) in the elderly.

Location(s):
France

Year Started: 2008

Design:
Observational, Cohort, Prospective.

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.

Patient Involvement:
Participants will be randomized to one of 5 groups: surgical randomized, endovascular randomized, surgical observational prospective, endovascular observational prospective, and abstention observational prospective. Subjects will complete a Modified Rankin Scale score, Mini Mental State Examination, Quality of LIfe, QLQ C30 questionnaire from EORTC, self-maintaining and instrumental activities of daily living, ADL and IADL score 12 months post randomization.

Primary Outcome:
Modified Rankin Scale score.

Secondary Outcome:
Mini Mental State Examination; Quality of LIfe, QLQ C30 questionnaire from EORTC; self-maintaining and instrumental activities of daily living, ADL and IADL score; hydrocephalus and risk factors; causes of morbidity and mortality.

Source of Information:
ClinicalTrial.gov

Web Links and Publications:
International Subarachnoid Aneurysm Trial of Neurosurgical Clipping Versus Endovascular Coiling. Subgroup Analysis of 278 Elderly Patients.
Stroke 2008 Jul 31;

French Society of Neurosurgeons

FASHE
ClincalTrials.gov

This information last updated on: 5/25/2010

Reviewed on: 05/25/2010.

UID: 886

   

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