Trial document




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  DRKS00007902

Trial Description

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Title

Comparison of ROTEM® derived parameters from venous and intraosseous blood

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Trial Acronym

ROTEM® i.o.

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URL of the Trial

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Brief Summary in Lay Language

In trauma patients it`s often difficult to get an intravenous access (access to a blood vessel in order to take blood or administer medication) due to a circulatory mismatch. But time is an important factor in maintenance of this specific patient group and long-lasting procedures cause a delay in initiation of diagnostics and treatment and thus worsen the outcome. Therefore, current guidelines recommend puncturing the bone cave on the lower limb in order to administer drugs or draw some blood for further diagnostics. The so called Rotational thrombelastometry (ROTEM) is a blood test which allows a rapid diagnostic of dysfunction within the coagulation process in bleeding trauma patients. Results of this coagulation test allow a targeted therapy of the underlying cause of bleeding. To date, there is no data if intravenously and intraosseous drawn blood provide equivalent results in this test. The aim of the study is to compare ROTEM derived parameters from intravenous and intraosseous blood in healthy probands as well as in patients from the emergency department.

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Brief Summary in Scientific Language

Viscoelastic hemostatic assays are valuable tools for guidance of coagulation therapy in severe trauma and – as a point of care testing tool - can provide more rapid results compared to standard laboratory coagulation tests.
Establishing venous access can be challenging in trauma patients and precious time is lost frequently. Hence, current guidelines of the European Resuscitation Council state, that intra osseous access should be performed if two conventional attempts for obtaining venous access have failed in emergency patients. Therefore, an increasing number of these patients receive intra osseous access, at least initially.
A large number of drugs can be administered via the intra osseous route and also blood samples can be drawn to perform diagnostic tests. Some laboratory tests lead to comparable results when performed with venous or intra osseous blood.
To date there is no data regarding comparability of viscoelastic hemostatic test results done via venous or intra osseous access.
The aim of this study is to compare ROTEM® derived test parameters from intravenous and intra osseous blood.

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Organizational Data

  •   DRKS00007902
  •   2015/04/07
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  •   yes
  •   Approved
  •   1699/2014, Ethikkommission der Medizinischen Universität Wien Borschkegasse 8b/6 A-1090 Wien, Austria T +43 1 40 400 – 21470, 22440 F +43 1 40 400 – 16900 ethik-kom@meduniwien.ac.at ethikkommission.meduniwien.ac.at
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Secondary IDs

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Health Condition or Problem studied

  •   T79.2 -  Traumatic secondary and recurrent haemorrhage
  •   healthy probands
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Interventions/Observational Groups

  •   Part1 of the study: analysis of ROTEM derived parameters from venous and intraosseus blood in healthy subjects
  •   Part2 of the study: analysis of ROTEM derived parameters from venous and intraosseus blood in traumatic patients
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

comparability of ROTEM derived Parameters of intravenous and intraosseous blood

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Secondary Outcome

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/07/01
  •   161
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Adult, healthy volunteers (male and female) without any known coagulation disorder; written informed consent; patients with polytrauma

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Exclusion Criteria

• Ingestion of substances* known to influence coagulation tests
• Pregnancy
• breast-feading women
• age < 18à and > 99à

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Addresses

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    • Medizinische Universität Wien
    • Mr.  Univ.-Prof. Dr. med.  Klaus  Markstaller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • AKH Wien Abteilung für Anästhesie, Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Marion  Wiegele 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • AKH Wien Abteilung für Anästhesie, Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Marion  Wiegele 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Medizinische Universität Wien
    • Mr.  Univ.-Prof. Dr. med.  Klaus  Markstaller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • Österreichische Gesellschaft für Anästhesie, Reanimation und Intensivmedizin (ÖGARI)
    • Ms.  Eva  Gottfried 
    • Höfergasse 1A/Stg.1/DG/Top 15
    • 1090  Wien
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/19
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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.