Trial document




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  DRKS00017215

Trial Description

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Title

Analyses of extrinsic and intrinsic factors which regulate the immune modulation in polytrauma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

During the last three decades our understanding of trauma-induced pathomechanisms has markedly developed. However, the complication and mortality rates after (poly)trauma still remain alarming high.
The aim of the present study is to elaborate the mechanisms and potential biomarker for regenerative disturbances and detrimental outcomes after trauma.

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Brief Summary in Scientific Language

In this large, mono-center trial the polytraumatized patients and as controls, healthy volunteers, will be included.
Based on the data the following questions should be addressed:
1. How does trauma modulate the production and release of danger molecules, mediators, coagulation factors and other defined biomarker? How is this depending on trauma injury or the severity of injury? How are the factors correlating with outcomes?
2. How do age and gender modulate the production and release of danger molecules, mediators, coagulation factors and other defined biomarker? How is this depending on trauma injury or the severity of injury? How are these factors correlating with outcomes?
3. How does alcohol abuse modulate the production and release of danger molecules, mediators, coagulation factors and other defined biomarker? How is this depending on trauma injury or the severity of injury? How are these factors correlating with outcomes?
4. How do chronic diseases modulate the production and release of danger molecules, mediators, coagulation factors and other defined biomarker? How is this depending on trauma injury or the severity of injury? How are these factors correlating with outcomes?

We expect following:
1. To characterize the concentration and kinetics of mediators and danger molecules as well as biomarkers after polytrauma.
2. To determine the correlations and associations between these molecules with the specific injury pattern/severity and clinical outcomes.
3. To determine the correlations of age, gender, chronic diseases, alcohol abuse, and associations between these molecules with the specific injury pattern/severity and clinical outcomes.

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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

  •   DRKS00017215
  •   2019/05/20
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  •   yes
  •   Approved
  •   89/19, 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

  •   S28 -  Crushing injury of thorax and traumatic amputation of part of thorax
  •   T89 -  [---]*
  •   T81 -  Complications of procedures, not elsewhere classified
  •   T88 -  Other complications of surgical and medical care, not elsewhere classified
  •   T79 -  Certain early complications of trauma, not elsewhere classified
  •   T93 -  Sequelae of injuries of lower limb
  •   T94 -  Sequelae of injuries involving multiple and unspecified body regions
  •   T90 -  Sequelae of injuries of head
  •   I97 -  Postprocedural disorders of circulatory system, not elsewhere classified
  •   R57 -  Shock, not elsewhere classified
  •   I50 -  Heart failure
  •   D65 -  Disseminated intravascular coagulation [defibrination syndrome]
  •   V99 -  Unspecified transport accident
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Interventions/Observational Groups

  •   Group 1: healthy volunteers
    non-interventional other study
    monocenter study
    In both groups blood sampling will be performed. There are no planned special other interventions.
    For group 1, which serves as a reference group, a single blood sample is taken.
  •   Group 2: polytraumatized patients
    observational study
    monocenter study

    In both groups blood sampling will be performed. There are no planned special other interventions.
    Group 1 is the reference group. Group 2 includes severely injured trauma patients and blood will be taken at the following time points:
    1h, Days: 1, 2, 3, 5, 7 and 10 post trauma.

    1. How does trauma modulate the release of danger molecules and biomarkers in injury severity- and injury pattern-dependent manner? How does this influence the outcome regarding organ complications and mortality during the time course?
    2. How do age and gender modulate the release of danger molecules and biomarkers in injury severity- and injury pattern-dependent manner? How does this influence the outcome regarding organ complications and mortality during the time course?
    3. How does chronical alcohol abuse modulate the release of danger molecules and biomarkers in injury severity- and injury pattern-dependent manner? How does this influence the outcome regarding organ complications and mortality during the time course?
    4. How do chronic diseases modulate the release of danger molecules and biomarkers in injury severity- and injury pattern-dependent manner? How does this influence the outcome regarding organ complications and mortality during the time course?
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- cytokine-/chemokine profiles
- coagulation factors
- miRNA 
- cell damage and function marker
- cells
- organ functions
- diagnoses 
- duration of the stay at the intensive care unit and hospital
- organ failure, mortality

Time points for sampling:
- upon admission
- day 1
- day 2
- day 3
- day 5
- day 7
- day 10

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Secondary Outcome

- differential blood analysis (clinical routine)
- infections (pneumonia, wound infections, etc.) (clinical routine)
- SIRS, severe SIRS (clinical routine)
- sepsis, severe sepsis, septic shock
- shock severity (katecholamin concentration)
- organ dysfunctions (SOFA score)
- injury severity (ISS)
- disease severity (APACHE II, SAPS II, SAPS 3)
- regenerative disturbances (clinical routine)
- complications (clinical routine)
- mortality 
- clinical data from the German Trauma Registry
- transfusion (clinical routine, BGAs)
- perioperative complications e.g. lung embolism, myocardial infarction

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/01
  •   550
  •   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

- Age > 18 years
- Polytrauma with an ISS ≥ 16
- regular termination of the "shock room" phase
- signed informed consent

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Exclusion Criteria

- patients younger then 18
- burn injury
- death within 24 hours post trauma
- ISS < 16

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Addresses

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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Frankfurt, Goethe Universität
    • 60590  Frankfurt
    • Germany
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    •   0049-69-6301-6123
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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie Klinik der J W Goethe-Universität
    • Mr.  Prof.   Ingo  Marzi 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Frankfurt, Goethe Universität
    • Mr.  Prof.  Ingo  Marzi 
    • Theodor Stern Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie
    • 60590  Frankfurt
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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