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

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Brief Title

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

Official Title

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

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.
    

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.
    


Study Type

Observational


Primary Outcome

Modified Rankin Scale score

Secondary Outcome

 Min Mental State Examination

Condition

Aneurysmal Subarachnoid Hemorrhage


Study Arms / Comparison Groups

 Randomized microsurgical
Description:  After randomization, this group was constituted of patients treated by microsurgical clipping.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

353

Start Date

October 2008

Completion Date

January 2014

Primary Completion Date

January 2014

Eligibility 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
      

Gender

All

Ages

70 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

François PROUST, M.D., Ph.D., , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00692744

Organization ID

2007/042/HP


Responsible Party

Sponsor

Study Sponsor

University Hospital, Rouen


Study Sponsor

François PROUST, M.D., Ph.D., Principal Investigator, Rouen University Hospital


Verification Date

September 2014