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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00692744
First received: June 3, 2008
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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.


Condition
Aneurysmal Subarachnoid Hemorrhage
Hydrocephalus
Cerebral Vasospasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Modified Rankin Scale score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Min Mental State Examination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of LIfe, QLQ C30 questionnaire from EORTC [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Self-maintaining and instrumental activities of daily living, ADL and IADL score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Hydrocephalus and risk factors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Causes of morbidity and mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

2 randomized arms (clipping and coiling) and 3 prospective observational arms (clipping, coiling, conservative) For the randomized arms, we anticipated 20 patients in each arm.


Enrollment: 353
Study Start Date: October 2008
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Randomized microsurgical
After randomization, this group was constituted of patients treated by microsurgical clipping.
Randomized endovascular
After randomization, this group was constituted of patients treated by endovascular coiling.
Prospective observational microsurgical
The randomization was ethically unsuitable because of the aneurysm predisposed to the microsurgical clipping after discussion into the neurovascular interdisciplinary team.
Prospective observational endovascular
The randomization was ethically unsuitable because of the aneurysm morphology predisposed to the endovascular coiling after discussion into the neurovascular interdisciplinary team.
Prospective observational conservative
This group was constituted of patients whom no curative treatment of the aneurysm sac could not be proposed.

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.

  Eligibility

Ages Eligible for Study:   70 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary cara clinic in differents countries of France

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692744

Locations
France
PROUST
Rouen, France, 76031
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: François PROUST, M.D., Ph.D. Rouen University Hospital
Principal Investigator: Serge BRACARD, M.D., Ph.D. Nancy University Hospital
Study Director: Guillaume PENCHET, M.D. Bordeaux University Hospital
Study Director: Evelyne EMERY, M.D. University Hospital, Caen
Study Director: Bernard IRTHUM, M.D. Clermont University Hospital
Study Director: Klaus MOURIER, M.D. Dijon University Hospital
Study Director: Emmanuel GAY, M.D. University Hospital, Grenoble
Study Director: Jean-Paul LEJEUNE, M.D. Lille University Hospital
Study Director: Isabelle PELISSOU, M.D. Lyon University Hospital
Study Director: Pierre Hughes ROCHE, M.D. Marseille University Hospital
Study Director: Thierry CIVIT, M.D. Nancy University Hospital
Study Director: Michel LONJON, M.D. Nice University Hospital
Study Director: Philippe DAVID, M.D. Paris University Hospital
Study Director: Benoit BATAILLE, M.D. Poitiers University Hospital
Study Director: Xavier MORANDI, M.D. Rennes University Hospital
Study Director: Jacques LAGUARRIGUE, M.D. Toulouse University Hospital
Study Director: Romain BILLON-GRAND, M.D. Besançon University Hospital
Study Director: Damien BRESSON, M.D. Paris University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00692744     History of Changes
Other Study ID Numbers: 2007/042/HP
Study First Received: June 3, 2008
Last Updated: September 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Subarachnoid hemorrhage
Cerebral aneurysm
Elderly

Additional relevant MeSH terms:
Brain Diseases
Hemorrhage
Hydrocephalus
Subarachnoid Hemorrhage
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Intracranial Hypertension
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014