NCT00692744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

5.3 years

First QC Date

June 3, 2008

Last Update Submit

September 1, 2014

Conditions

Aneurysmal Subarachnoid HemorrhageHydrocephalusCerebral Vasospasm

Keywords

Subarachnoid hemorrhageCerebral aneurysmElderly

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale score

    12 months

Secondary Outcomes (5)

  • Min Mental State Examination

    12 months

  • Quality of LIfe, QLQ C30 questionnaire from EORTC

    12 months

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

    12 months

  • Hydrocephalus and risk factors

    12 months

  • Causes of morbidity and mortality

    12 months

Study Arms (5)

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.

Eligibility Criteria

Age70 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary cara clinic in differents countries of France

You may qualify if:

  • 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

You may not qualify if:

  • Patients in grade V of WFNS scale
  • Subarachnoid hemorrhage without cerebral aneurysm
  • Patients with cerebral dementia, neurologic or psychiatric antecedents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PROUST

Rouen, 76031, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (2)

  • Proust F, Gerardin E, Derrey S, Lesveque S, Ramos S, Langlois O, Tollard E, Benichou J, Chassagne P, Clavier E, Freger P. Interdisciplinary treatment of ruptured cerebral aneurysms in elderly patients. J Neurosurg. 2010 Jun;112(6):1200-7. doi: 10.3171/2009.10.JNS08754.

    PMID: 19961311BACKGROUND

  • Proust F, Bracard S, Thines L, Leclerc X, Penchet G, Berge 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, Courtheoux 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. No abstract available. French.

    PMID: 20060549BACKGROUND

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.

MeSH Terms

Conditions

Subarachnoid HemorrhageHydrocephalusVasospasm, IntracranialIntracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial Arterial DiseasesAneurysm

Study Officials

  • François PROUST, M.D., Ph.D.

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

  • Serge BRACARD, M.D., Ph.D.

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

  • Guillaume PENCHET, M.D.

    University Hospital, Bordeaux

    STUDY DIRECTOR

  • Evelyne EMERY, M.D.

    University Hospital, Caen

    STUDY DIRECTOR

  • Bernard IRTHUM, M.D.

    Clermont University Hospital

    STUDY DIRECTOR

  • Klaus MOURIER, M.D.

    Centre Hospitalier Universitaire Dijon

    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.

    Hospices Civils de Lyon

    STUDY DIRECTOR

  • Pierre Hughes ROCHE, M.D.

    University Hospital, Marseille

    STUDY DIRECTOR

  • Thierry CIVIT, M.D.

    Central Hospital, Nancy, France

    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.

    University Hospital, Toulouse

    STUDY DIRECTOR

  • Romain BILLON-GRAND, M.D.

    Besançon University Hospital

    STUDY DIRECTOR

  • Damien BRESSON, M.D.

    Paris University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

FR(2)