Trial document




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  DRKS00011106

Trial Description

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Title

ECMO/ECLS: systemic inflammation and interference of homeostasis in patients with extracorporeal heart-/lungsupport

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

An ECMO (ExtraCorporeal Membrane Oxygenation) or ECLS (ExtraCorporeal Life Support) is a machine which, in cases of acute lung or heart failure, can take on the function of the failing organ - at least for some time. This machine works outside the body and is connected over several arterial and/venous vascular access lines. For some time now it is known, that an ECMO/ECLS is going on with an inflammation of the blood or can have influance of hemostasis. With this study we want to investigate if and in which extend an ECMO/ECLS influences inflammation and hemostasis of the blood. As part of several blood samples parameters of inflammation and their effect on other cells will be investigated. Furthermore influences of ECMO/ECLS on hemostasis will be looked at. Due to those results the role of systemic inflammation and hemostasis in patients with ECMO/ECLS will be further understood and in future therapies of patients with ECMO/ECLS might be optimised.

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Brief Summary in Scientific Language

An ECMO (ExtraCorporeal Membrane Oxygenation) or ECLS (ExtraCorporeal Life Support) is an extracorporeal replacement therapy which can temporarily replace the function of the lung and/or heart during acute organe failure, e.g. in cardiogenic shock, ARDS or SIRS in sepsis. Out of clinical experience, therapy with ECMO/ECLS is suspected to have influence on hemostasis and inflammation in the patients blood. Thrombembolic complications are seen as well as bleeding incidents. With this study we want to investigate the basic principles of changes in hemostasis and inflammation in patients with ECMO/ECLS therapy. Therefore bloodsamples will be taken at several points in time before, during and after EMCO/ECLS therapy.
Those samples will be investigated with standardized laboratory methods on the one hand and specialized analytical methods (e.g. FACS, PCR, protein analysis) in the laboratory of the study coordinator on the other hand.
Due to the heterogenity of the patient collective, intraindividuell comparisons over the time of therapy will be brought into focus. Changes of hemostasis and inflammation will then be correlated with relevant clinical events and the clinical outcome of the patients.

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Organizational Data

  •   DRKS00011106
  •   2016/09/22
  •   [---]*
  •   yes
  •   Approved
  •   585/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   patients with acute heart- and/or lungfailure
  •   R57.0 -  Cardiogenic shock
  •   J80 -  Adult respiratory distress syndrome
  •   R65 -  Systemic Inflammatory Response Syndrome [SIRS]
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Interventions/Observational Groups

  •   blood sample from patients with ECMO/ECLS will be taken at several points in time before, during and after EMCO/ECLS therapy.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

detection of changes in hemostasis and vascular inflammation using blood test (standardized laboratory methods and specialized analytical methods (e.g. FACS, PCR, protein analysis) in the laboratory of the study coordinator)) before, during and after ECMO/ECLS support

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Secondary Outcome

correlation of criteria 1) with survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/10/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with ECMO/ECLS

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Exclusion Criteria

hemato-oncological basic disease;
severe anemia requiring transfusions (Hb < 7 g/dl)

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Addresses

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    • Universitätsherzzentrum Freiburg - Bad KrozingenAbteilung Kardiologie und Angiologie I
    • Mr.  Prof. Dr. med.  Christoph  Bode 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsherzzentrum Freiburg - Bad KrozingenAbteilung Kardiologie und Angiologie I
    • Mr.  PD Dr. med.  Philipp  Diehl 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsherzzentrum Freiburg - Bad KrozingenAbteilung Kardiologie und Angiologie I
    • Mr.  Dominik  Hentschel 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsherzzentrum Freiburg - Bad KrozingenAbteilung Kardiologie und Angiologie I
    • Mr.  Prof. Dr. med.  Christoph  Bode 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.