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Admission Bio-clinical Score to Predict One-year Outcomes in Coiled Subarachnoid Hemorrhage (SAH) (ABCSAH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01357057
First received: May 16, 2011
Last updated: December 27, 2011
Last verified: May 2011
History of Changes
  Purpose

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).


Condition
Aneurysmal Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Biological Markers in Patients Presenting Aneurism Coiling for Subarachnoid Hemorrhage

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Mortality and Full recovery (Rankin 0-1) at ICU discharge [ Time Frame: at 1-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early cerebral complication [ Time Frame: Within the first week of ICU stay ] [ Designated as safety issue: No ]
    aneurysm rebleeding, intracranial hypertension, acute hydrocephalus, coiling complication

  • Delayed cerebral complication [ Time Frame: for the duration of hospital stay, an expected average of 3 weeks with an expected maximum of 3 months ] [ Designated as safety issue: No ]
    vasospasm, ischemic vasospasms and chronic


Enrollment: 530
Study Start Date: January 2003
Study Completion Date: September 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Derivation cohort
Arm 1: Derivation cohort (from 2003 to 2007)
Validation cohort
Arm 2: Validation cohort (from 2008 to 2009)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult coiled SAH after ICU admission

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other intervention than coiling (surgery of nor surgery, nor coiling intervention)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357057

Locations
France
Neuro-réanimation Chirurgicale Babinski - Hopital Pitié Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Louis Puybasset, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01357057     History of Changes
Other Study ID Numbers: P04806
Study First Received: May 16, 2011
Last Updated: December 27, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Medical records
Outcome scale
Biological biomarkers

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013