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

Hydrocephalus Clinical Trial

— FASHE  

Official title:

Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692744
• Other study ID #: 2007/042/HP
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: September 1, 2014
• Start date: October 2008
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Cerebral Vasospasm
• Hemorrhage
• Hydrocephalus
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
France	PROUST	Rouen
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

References & Publications (2)

Proust F, Bracard S, Thines L, Leclerc X, Penchet G, Bergé J, Vignes JR, Irthum B, Gabrillargues J, Chazal J, Bataille B, Drouinau J, Mourier K, Ricolfi F, Gay E, Bessou P, Lonjon M, Sedat J, David P, Lajaunias P, Morandi X, Gauvrit JY, Pelissou I, Turjman F, Roche PH, Dufour H, Levrier O, Emery E, Courthéoux P, Laguarrigue J, Cognard C, Civit T, Lejeune JP. [Aneurismal subarachnoid hemorrhage in the elderly subject. Should this patient participate in a randomized clinical trial?]. Neurochirurgie. 2010 Feb;56(1):67-72. doi: 10.1016/j.neuchi.2009.11.002. Epub 2010 Jan 8. French. — View Citation

Proust F, Gérardin E, Derrey S, Lesvèque S, Ramos S, Langlois O, Tollard E, Bénichou J, Chassagne P, Clavier E, Fréger P. Interdisciplinary treatment of ruptured cerebral aneurysms in elderly patients. J Neurosurg. 2010 Jun;112(6):1200-7. doi: 10.3171/2009.10.JNS08754. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale score		12 months	Yes
Secondary	Min Mental State Examination		12 months	Yes
Secondary	Quality of LIfe, QLQ C30 questionnaire from EORTC		12 months	Yes
Secondary	Self-maintaining and instrumental activities of daily living, ADL and IADL score		12 months	Yes
Secondary	Hydrocephalus and risk factors		12 months	Yes
Secondary	Causes of morbidity and mortality		12 months	Yes