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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00692744
Other study ID # 2007/042/HP
Secondary ID
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


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
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