Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009876

Trial Description

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Title

Trauma-induced long-term immune paralysis

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Trial Acronym

TRIP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To answer the question of
long-term injuries of immunsystem by a relevant trauma this pilot study is to examine blood samples and clinical progress of badly injured patients after half a year.

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Brief Summary in Scientific Language

Severe injuries are asssociated with the systemic inflammatory response syndrome (SIRS). The reaction starts within 30min after trauma and is the immune reaction to blood loss and tissue damage rather than infection. Trauma also leads to immune suppression. So far it isn´t checked how long this influence on immune system after trauma lasts.
A lot of studies show the HLA-DR-complex on monocytes to be a valid surrogate of their global function. The HLA-DR-expression on monocytes is significantly reduced after trauma. This pilot study is to answer the question of long-term injuries and paralysis of immunsystem by a relevant trauma.

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Organizational Data

  •   DRKS00009876
  •   2016/11/08
  •   [---]*
  •   yes
  •   Approved
  •   26/16, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   T07 -  Unspecified multiple injuries
  •   D83.9 -  Common variable immunodeficiency, unspecified
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Interventions/Observational Groups

  •   HLA-DR-expression 6 month after severe trauma
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

6 month after severe trauma: immunological phenotype of T-cells and monocytes via zytometric reading

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

6 month after severe multiple trauma, admission on ICU

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Exclusion Criteria

viral infection hepatitis A/B/C, HIV infection

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Addresses

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    • Universitätsklinikum Gießen und Marburg
    • Abteilung für Anästhesie 
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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    • Abteilung für Anästhesie, Universitätsklinikum Gießen und Marburg
    • Ms.  Sophie  Ruhrmann 
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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    • Abteilung für Anästhesie, Universitätsklinikum Gießen und Marburg
    • Ms.  Sophie  Ruhrmann 
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Gießen und Marburg
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/01
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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.