Trial document





This trial has been registered retrospectively.
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  DRKS00004378

Trial Description

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Title

Differentiation between cerebral ischemia and intracerebral hemorrhage in patients with acute stroke.

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Trial Acronym

BE FAST II

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We are collecting blood samples and clinical data of patients with symptoms of acute stroke within 6 hours of symptom onset. The laboratory analysis of GFAP (a brain protein) in the blood of patients may help us to differenciate between the two major subtypes of stroke, cerebral ischemia or intracerebral bleeding.

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Brief Summary in Scientific Language

The aim of this prospective study is to estimate sensitivity, specificity as well as positive and negative predictive values of GFAP for differenciating between cerebral ischemia and intracerebral hemorrhage in patients admitted with symptoms of acute stroke.

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Organizational Data

  •   DRKS00004378
  •   2012/10/04
  •   [---]*
  •   yes
  •   Approved
  •   236/05, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I61 -  Intracerebral haemorrhage
  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   Blood draw in the process of emergency care/ management. No further study-related measures.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Diagnostic accuracy of a GFAP biomarker test (ROC-analysis: sensitivity, specificity, predictive positive and negative value) for differentiating intracerebral hemorrhage from cerebral ischemia.

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Secondary Outcome

Identification of possible correlation of GFAP-serum levels with localisation and size of the hemorrhage.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/03
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

symptoms of stroke < 6 hours, NIHSS >= 4 points

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Exclusion Criteria

stroke within the last 3 months, history of brain tumor, traumatic brain injury within the last 3 months

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Addresses

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    • Klinikum der Johann Wolfgang Goethe-Universität Zentrum der Neurologie und Neurochirurgie
    • Mr.  PD Dr. med.  Christian  Förch 
    • Schleusenweg 2-16
    • 60528  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe-Universität Zentrum der Neurologie und Neurochirurgie
    • Mr.  PD Dr. med.  Christian  Förch 
    • Schleusenweg 2-16
    • 60528  Frankfurt
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinikum der Johann Wolfgang Goethe-Universität Zentrum der Neurologie und Neurochirurgie
    • Mr.  PD Dr. med.  Christian  Förch 
    • Schleusenweg 2-16
    • 60528  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Roche Diagnostics GmbH
    • Sandhöfer Allee
    • 68305  Mannheim
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/09/02
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* This entry means the parameter is not applicable or has not been set.