Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010035

Trial Description

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Title

ECMO, ECLS and VAD in children with DP3

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Trial Acronym

DP3

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URL of the Trial

http://keine

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Brief Summary in Lay Language

In case of severe haeart - or heart and lung failure children might die, when all surgical or medical treatment fails. MEchanical circulatory support might be a chance to survive until recovery or heart transplantation.
With this multicentre study we want to evaluate the feasibility, efficacy and the complication- and survival rate of a new miniaturized third generation diagonal centrifugal pump, used in Europe in 241 neonatal and pediatric consecutive Patients from seven centres.

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Brief Summary in Scientific Language

With technical improvement mechanical circulatory support for heart and/or lung failure became routine in specialized neonatal and pediatric cardiac centres. We will focus on the first multicentre trial with a new miniaturized third generation diagonal centrifugal pump. Its a pump system with 16 ml priming volume, able to generate a flow of below 0.5 up to 8 litres per minute.
We will proove the pumps feasibility, efficacy and complication rate.
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Organizational Data

  •   DRKS00010035
  •   2016/02/25
  •   [---]*
  •   yes
  •   Approved
  •   6015, International Medical and Dental Ethics Commission GmbH Freiburg im Breisgau
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Secondary IDs

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

  •   Q20-Q28 -  Congenital malformations of the circulatory system
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Interventions/Observational Groups

  •   multicentre retrospective data analysis of the Medos DP-3 life-support system in children.
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Characteristics

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

survival

Hypothesis:
The DP3 brings improvement regarding the older mechancial supporting systems. Patients are recorded until discharge home.

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Secondary Outcome

complication rate (Bleeding and thrombosis), until discharge home.

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Countries of Recruitment

  •   Germany
  •   Netherlands
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Locations of Recruitment

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

  •   Actual
  •   2015/03/02
  •   240
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   17   Years
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Additional Inclusion Criteria

severe heart- or heart and lung failure and the need for mechanical circulatory support with the DP3, from 2011 until 4/2015

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Exclusion Criteria

Age > 17 years, no need for mechanical circulatory support

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Herzzentrum Freiburg Bad Krozingen
    • Ms.  Prof. Dr. med.  Brigitte  Stiller 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • Universitäts Herzzentrum Freiburg Bad Krozingen
    • Ms.  Prof. Dr.   Brigitte  Stiller 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • Universitäts Herzzentrum Freiburg Bad Krozingen
    • Ms.  Prof. Dr.  Brigitte  Stiller 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.