Ignite Creation Date:
2024-05-05 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00692744
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2008-06-03
Brief Title:
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage SAH
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASHE
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None