Trial document




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  DRKS00017683

Trial Description

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Title

Preclinical external compression in pelvic injuries

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Trial Acronym

pelvic2bind

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Severely injured patients with possible pelvic injury routinely receive an external compression device (pelvic binder) from emergency personnel. This procedure is backed by valid medical guidelines but put into practice very differently on an international level. We plan to perform an online survey among physicians about regional proceedings and experiences with pelvic binders.

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Brief Summary in Scientific Language

More than 25 % of polytraumatized patients incur a pelvic injury. In case of pelvic instability and hemorrhagic shock, German guidelines recommend placement of a pelvic binder. The procedure however is quite different regionally and internationally. We aim to perform an online survey among physician colleagues in 26 countries (country region 15 of the American College of Physicians) to elucidate regional preclinical and intraclinical treatment of pelvic injuries.

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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

  •   DRKS00017683
  •   2019/09/27
  •   [---]*
  •   yes
  •   Approved
  •   2019-14372, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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

  •   S32.7 -  Multiple fractures of lumbar spine and pelvis
  •   R57.1 -  Hypovolaemic shock
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Interventions/Observational Groups

  •   Peer Physicians from 26 countries will be asked about their proceedings and experiences with pelvic binders
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Characteristics

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

To elucidate the regional difference in standard operating procedures and infrastructure in preclinical and intraclinical treatment of pelvic injuries.

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Secondary Outcome

The trial seeks to elucidate experience and use of pelvic binders in pelvic injuries by physicians in an internet-based questionnaire. Therefore no typical primary and secondary outcomes.

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Countries of Recruitment

  •   Cyprus
  •   Czech Republic
  •   Denmark
  •   Estonia
  •   France
  •   Georgia
  •   Germany
  •   Ghana
  •   Greece
  •   Hungary
  •   Ireland
  •   Israel
  •   Italy
  •   Jamaica
  •   Kenya
  •   Lithuania
  •   Moldova, Republic of
  •   Netherlands
  •   Norway
  •   Portugal
  •   Slovenia
  •   South Africa
  •   Spain
  •   Sweden
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/10/14
  •   500
  •   Monocenter trial
  •   International
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Inclusion Criteria

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

Physicians that are charged with the in-house treatment of severly injured patients

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Exclusion Criteria

nonparticipation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Marienhaus Klinikum Hetzelstift
    • Mr.  PD Dr.  Christoph  Wölfl 
    • Stiftstraße 10
    • 67434  Neustadt
    • Germany
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    • Marienhaus Klinikum Hetzelstift
    • Mr.  PD Dr.  Christoph  Wölfl 
    • Stiftstraße 10
    • 67434  Neustadt
    • Germany
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    • Marienhaus Klinikum Hetzelstift
    • Mr.  PD Dr. med.  Christoph  Wölfl 
    • Stiftstraße 10
    • 67434  Neustadt
    • Germany
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Sources of Monetary or Material Support

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    • Marienhaus Klinikum Hetzelstift
    • Mr.  PD  Christoph  Wölfl 
    • Stiftstraße 10
    • 67434  Neustadt
    • Germany
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Status

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

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