NCT01357057

Brief Summary

The goal of this observational study is to develop and validate a predictive score of 1-year outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling. Using our database filled up prospectively, the investigators plan to collect clinical, biological and radiological admission characteristics of coiled SAH cases and their 1-year Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score in a validation cohort (from 2008 to 2009).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2003

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

May 1, 2011

Enrollment Period

8 years

First QC Date

May 16, 2011

Last Update Submit

December 27, 2011

Conditions

Keywords

Medical recordsOutcome scaleBiological biomarkers

Outcome Measures

Primary Outcomes (1)

  • Mortality and Full recovery (Rankin 0-1) at ICU discharge

    at 1-year

Secondary Outcomes (2)

  • Early cerebral complication

    Within the first week of ICU stay

  • Delayed cerebral complication

    for the duration of hospital stay, an expected average of 3 weeks with an expected maximum of 3 months

Study Arms (2)

Derivation cohort

Arm 1: Derivation cohort (from 2003 to 2007)

Validation cohort

Arm 2: Validation cohort (from 2008 to 2009)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult coiled SAH after ICU admission

You may qualify if:

  • Older than 18 years old
  • Acute aneurysmal subarachnoid hemorrhage
  • Decision of coiling intervention
  • Admission and ICU management in our center.

You may not qualify if:

  • Other intervention than coiling (surgery of nor surgery, nor coiling intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuro-réanimation Chirurgicale Babinski - Hopital Pitié Salpetriere

Paris, 75013, France

Location

Related Publications (1)

  • Degos V, Apfel CC, Sanchez P, Colonne C, Renuit I, Clarencon F, Nouet A, Boch AL, Pourmohamad T, Kim H, Gourraud PA, Young WL, Puybasset L. An admission bioclinical score to predict 1-year outcomes in patients undergoing aneurysm coiling. Stroke. 2012 May;43(5):1253-9. doi: 10.1161/STROKEAHA.111.638197. Epub 2012 Feb 23.

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Louis Puybasset, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 20, 2011

Study Start

January 1, 2003

Primary Completion

January 1, 2011

Study Completion

September 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-05

Locations