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NCT Number: NCT00692744

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

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.

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Vasospasm Cerebrovascular Disorders Hemorrhage Hydrocephalus Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm, Intracranial

Age range

70 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PROUST, Rouen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Modified Rankin Scale score

    Time frame: 12 months

Secondary outcomes

  1. Min Mental State Examination

    Time frame: 12 months

  2. Quality of LIfe, QLQ C30 questionnaire from EORTC

    Time frame: 12 months

  3. Self-maintaining and instrumental activities of daily living, ADL and IADL score

    Time frame: 12 months

  4. Hydrocephalus and risk factors

    Time frame: 12 months

  5. Causes of morbidity and mortality

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: FASHE

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2008
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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