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Trial record 29 of 195 for:    Hemorrhage AND SAH

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

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ClinicalTrials.gov Identifier: NCT01357057
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : December 29, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).


Condition or disease
Aneurysmal Subarachnoid Hemorrhage

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Biological Markers in Patients Presenting Aneurism Coiling for Subarachnoid Hemorrhage
Study Start Date : January 2003
Actual Primary Completion Date : January 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Bleeding

Group/Cohort
Derivation cohort
Arm 1: Derivation cohort (from 2003 to 2007)
Validation cohort
Arm 2: Validation cohort (from 2008 to 2009)



Primary Outcome Measures :
  1. Mortality and Full recovery (Rankin 0-1) at ICU discharge [ Time Frame: at 1-year ]

Secondary Outcome Measures :
  1. Early cerebral complication [ Time Frame: Within the first week of ICU stay ]
    aneurysm rebleeding, intracranial hypertension, acute hydrocephalus, coiling complication

  2. Delayed cerebral complication [ Time Frame: for the duration of hospital stay, an expected average of 3 weeks with an expected maximum of 3 months ]
    vasospasm, ischemic vasospasms and chronic



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357057


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01357057     History of Changes
Other Study ID Numbers: P04806
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: May 2011

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

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