Trial document




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  DRKS00004712

Trial Description

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Title

Developing new concepts for detecting, managing and preventing early
complications after acute ischemic stroke - the “Stroke Unit Plus” Observational study

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Trial Acronym

Stroke Unit Plus

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URL of the Trial

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Brief Summary in Lay Language

Introduction: Despite recent advances in acute treatment and management of stroke, prognosis after stroke is still severe. Current data indicate the relevance of early complications (such as pneumonia or inflammation) for prognosis of stroke. However, valid information of the frequency and natural course is limited. Therefore we aim to provide more comprehensive information about those early complications after stroke, which will help to support diagnostic and therapeutic decisions. Furthermore, on the basis of this information, we want to develop an interventional study in order to prevent or reduce those early complications and improve the overall individual outcome in stroke patients.

Objective 1: detect early complications after stroke, determine their natural course (e.g. timing and severity) and estimate their impact after three months
Objective 2: determine prognostic models for the occurrence of early complications after stroke on the basis of advanced diagnostic tests (blood tests, neuroimaging etc…)
Objective 3: develop strategies for future interventions to prevent and manage early complications after stroke successfully

Methods: This study will take 2 years. Patients with their first stroke are recruited in six stroke centres from the regions Berlin, Würzburg and Munich (Berlin Charité Campus Virchow Klinikum (CVK), Campus Charité Mitte (CCM), Campus Benjamin Franklin (CBF), Vivantes Klinikum Neukölln, Vivantes Klinikum Friedrichshain, Vivantes Auguste-Viktoria-Klinikum, Universitätsklinikum Würzburg, Klinikum Großhadern München). The study will be coordinated by the Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin in cooperation with the Institute of Clinical Epidemiology and Biometry (ICE-B), University of Würzburg. All eligible patients have baseline measures collected (f.e. blood pressure, temperature, EKG) and an intensive, standardised protocol of data collection related to early complications after stroke is performed (includes f.e. blood tests, tests for pneumonia, evaluation of pain). This is done the first 7 days or until discharge. After 3 months the outcome of stroke is measured by questioning over telephone or via postal questionnaire. For this study we want to recruit 1250 patients.

Inclusion criteria for patients
- age > 18- ischaemic stroke according to WHO definition, first ever stroke
- written informed consent for study participation from patient or their legal representative

Conclusion: The Stroke Unit Plus Observational study will develop prognostic models and inform strategies for future interventional studies to successfully prevent and manage early complications after stroke.

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Brief Summary in Scientific Language

Introduction: Although current data indicate the prognostic relevance of early complications in managing stroke patients, previous estimates of the frequency and natural course of early complications after stroke vary substantially and valid information is scarce. There are few prognostic models for predictors of early complications and the prognostic role of new diagnostic tests, results of imaging techniques, blood based biomarkers, subclinical disease determinants and genetic risk markers needs to be established. Therefore, there is currently insufficient evidence to define effective strategies for detection and management of early complications after stroke.
We aim to provide comprehensive information required to support early post stroke diagnostic and therapeutic decisions and to develop an intervention study to reduce the impact of early complications on individual outcome in ischemic stroke patients.

Objective 1: Systematically detect early complications after stroke, determine their natural course (e.g. timing and severity) and estimate their impact on three month outcome.
Objective 2: Determine prognostic models for the occurrence of early complications post stroke including results of advanced diagnostic tests, subclinical disease measures and genetic risk markers.
Objective 3: Developing strategies for future interventions to prevent and manage early complications after stroke successfully

Methods: A 2 year prospective multicenter cohort study, with consecutive ischemic stroke patients recruited in six stroke centres from the regions Berlin, Würzburg and Munich (Berlin Charité Campus Virchow Klinikum (CVK), Campus Charité Mitte (CCM), Campus Benjamin Franklin (CBF), Vivantes Klinikum Neukölln, Vivantes Klinikum Friedrichshain, Vivantes Auguste-Viktoria-Klinikum, Universitätsklinikum Würzburg, Klinikum Großhadern München). The study will be coordinated by the Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin in cooperation with the Institute of Clinical Epidemiology and Biometry (ICE-B), University of Würzburg. All eligible patients admitted to hospitals with first ever ischaemic stroke have baseline measures collected and an intensive, standardised protocol of data collection related to potential prognostic indicators over the first 7 days or until discharge. Primary outcome measure is death or dependency (Rankin Scale >3 or Barthel Index < 60) at 3 months with follow up by telephone or postal questionnaire. A sample of 1250 patients across all the centres is required. The number of explanatory variables and number of outcome events differ between the complications investigated and the exact multivariable models developed will depend on the distributional assumptions derived from the data available for each model.

Primary Outcome Measures: poor outcome after stroke after 3 months defined as death or dependency (modified Rankin Scale >3 or Barthel Index score < 60)
Secondary Outcomes: Occurrence of approximately 16 complications (not all will be applicable to all patients) at 3 months after stroke.
Inclusion criteria
- age > 18- ischaemic stroke according to WHO definition, first ever stroke
- written informed consent for study participation from patient or their legal representative

Hypotheses:
Hypophesis 1: We hypothesize that independent of potential confounders, such as age, sex, stroke severity and comorbidities, at least 20% of poor outcome three months after stroke [Rankin Scale >3 or Barthel Index < 60] is attributed independently to up to five main complications.
Hypophesis 2: We hypothesize that for the main complications influencing outcome after stroke we will be able to identify prognostic models that predict risk of occurrence of these complications with sufficient accuracy in terms of calibration and discrimination (e.g. an area under the ROC curve of at least 0.75).
Hypophesis 3: We hypothesize that we will be able to propose potentially effective strategies for reducing the impact of early complications on stroke outcome that will serve as the theoretical basis to be tested in an intervention study following the completion of the project.

Conclusion: The Stroke Unit Plus Observational study will develop prognostic models and inform strategies for future interventional studies to successfully prevent and manage early complications after stroke.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004712
  •   2013/09/04
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  •   yes
  •   Approved
  •   EA4/129/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   All eligible patients admitted to hospitals with first ever ischaemic stroke have baseline measures collected and an intensive, standardised protocol (see appendix) of data collection related to potential prognostic indicators of early complications after stroke over the first 7 days or until discharge. After 3 months a follow up by telephone or postal questionnaire will be executed.
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Characteristics

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

poor outcome after stroke after 3 months defined as death or dependency (modified Rankin Scale >3 or Barthel Index score < 60)

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Secondary Outcome

Occurrence of approximately 16 complications (not all will be applicable to all patients) at 3 months after stroke.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2013/09/06
  •   1250
  •   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

Inclusion criteria
- age >= 18- ischaemic stroke according to WHO definition, first ever stroke
- written informed consent for study participation from patient or their legal representative

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Exclusion Criteria

Exclusion criteria:
Patients initially diagnosed with stroke but subsequently proven to have alternative diagnosis.

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Addresses

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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Jan  Sobesky 
    • Charitéplatz1
    • 11017  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Matthias  Endres 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Ulrich  Dirnagl 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Andreas  Meisel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Wolfram  Doehner 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr. rer. nat.  Jens  Steinbrink 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr. phil.  Ian  Wellwood 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Campus Benjamin Franklin
    • Mr.  Univ.-Prof. Dr.  Heinrich  Audebert 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Campus Benjamin Franklin
    • Mr.  Univ.-Prof. Dr.  Golo  Kronenberg 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Campus Benjamin Franklin
    • Mr.  Dr. med.  Christian  Nolte 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Campus Benjamin Franklin
    • Mr.  Dr. med.  Gerhard  Jungehülsing 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Campus Benjamin Franklin
    • Mr.  Dr. med.  Karl Georg  Häusler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Vivantes Kliniken Berlin Vivantes Klinikum Neukölln
    • Mr.  Univ.-Prof. Dr.  Darius Günther  Nabavi 
    • Rudower Straße 48
    • 12351  Berlin
    • Germany
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    • Vivantes Kliniken Berlin Vivantes Klinikum im Friedrichshain
    • Mr.  Univ.-Prof. Dr.  Bruno-Marcel  Mackert 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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    • Vivantes Kliniken Berlin Vivantes Klinikum im Friedrichshain
    • Mr.  Priv.Doz. Dr.  Hans-Christian  Koennecke 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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    • Universitätsklinikum Würzburg
    • Mr.  Univ.-Prof. Dr.  Peter U.  Heuschmann 
    • Josef-Schneider-Str. 11
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum Würzburg
    • Mr.  Univ.-Prof. Dr.  Christoph  Kleinschnitz 
    • Josef-Schneider-Str. 11
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum Würzburg
    • Ms.  Dr. med.  Christiane  Drechsler 
    • Josef-Schneider-Str. 11
    • 97080  Würzburg
    • Germany
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    • Universität München Klinikum der Universität München
    • Mr.  Univ.-Prof. Dr.  Martin  Dichgans 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • VivantesHumboldt-Klinikum
    • Ms.  Univ.-Prof. Dr.  Bettina  Schmitz 
    • Am Nordgraben 2
    • 13509  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Jan  Sobesky 
    • Charitéplatz 1
    • 11017  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Univ.-Prof. Dr.  Jan  Sobesky 
    • Charitéplatz1
    • 11017  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Corona-Stiftung
    • Barkhovenallee 1
    • 45239  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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