NCT01569100

Brief Summary

The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins, have recently been demonstrated to improve endothelial function. Additionally, numerous studies have shown statins as having antiinflammatory and cell-signaling effects together with a selective up-regulation of the eNOS activity. These findings are of potential benefit for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed, one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and outcome at one year.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

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

Study Start

First participant enrolled

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

March 30, 2012

Last Update Submit

March 30, 2012

Conditions

SAH

Outcome Measures

Primary Outcomes (1)

  • S100B assay measured daily from days 1-15

    Day 1 through 15

Secondary Outcomes (1)

  • Ischemic lesion volume

    admission upon death or hospital discharge

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted between April 20, 2004, and October 1, 2007, to the Pitie- Salpetriere Teaching Hospital in Paris with aneurysmal SAH and treated by endovascular coiling or surgery within 96 hrs after SAH onset were considered for inclusion.

You may qualify if:

  • SAH patient \> 16 years-old admitted to the Pitie- Salpetriere Teaching Hospital
  • Securing procedure within 96 hours of bleeding

You may not qualify if:

  • Securing procedure \> 96 hours of bleeding
  • Rebleeding of original aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Louis Puybasset, Pr

    Departments of Anesthesiology and Critical Care, Pitie-Salpetriere Hospital, APHP, University Pierre et Marie Curie, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief of the Intensive Care Neurosurgical Unit

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 2, 2012

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 2, 2012

Record last verified: 2012-03