Trial document





This trial has been registered retrospectively.
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  DRKS00012821

Trial Description

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Title

Rotational thrombelastometry in oral anticoagulants

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Trial Acronym

ROAK

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The new oral anticoagulants dabigatran, edoxaban and rivaroxaban are to be investigated by means of rotational thrombelastometry. For this purpose, new tests are available, which are now to be evaluated in the laboratory and in clinical practice.
The standard laboratory tests for coagulation diagnostics and substance-specific laboratory tests are carried out as a comparison.
In addition, the effect of oral anticoagulants under anemia conditions is to be investigated.
For this purpose, blodd will be taken from healthy volunteeers to evaluate their blood by ROTEM or Standard laboratory testssamples resinated with rivaroxaban or dabigatran.
Evaluation in daily routine includes neurological patients with rivaroxaban or dabigatran for teh first time in their medication (for example after a stroke).
Blodd samples will be evaluated at different times (before first medication, after 2 hours, just before the second medication).
Goal of this study is the Evaluation of the new tests and the possibility to detect and evaluate patients with unclear bleeding and unknown intake of new oral anticoagulants.
Subsequent Change:
Edoxaban is being used more and more frequently and should therefore also be included in the study in order to prove a possible detection with the tests. An approval of the ethics committee has been made.

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Organizational Data

  •   DRKS00012821
  •   2018/01/11
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  •   yes
  •   Approved
  •   17-525, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   D68 -  Other coagulation defects
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Interventions/Observational Groups

  •   The new oral anticoagulants dabigatran and rivaroxaban are to be investigated by means of rotational thromboelastometry/thromboelastography. For this purpose, new tests are available, which should now be evaluated in the laboratory and clinical routine.
    The standard laboratory tests for coagulation diagnostics and substance-specific laboratory tests are compared.
    For evaluation in clinical routine, neurological patients should be examined. These are stroke patients who are readjusted to one of the two anticoagulants. At the time of first use, at the time of the presumed maximum effective level and shortly before second dose (minimum level), blood samples should be taken and examined.
    The aim is to evaluate the new tests in thromboelastometrie/thromboelastography in everyday clinical practice and to be able to detect the new oral anticoagulants in case of unclear bleeding.
  •   For the preparation and evaluation of the tests, first in-vitro preliminary tests are carried out.
    For this purpose, blood from healthy volunteers is mixed with the two active substances corresponding to different levels of effect (peak level, bottom level, maximum effective level, twice the effective level).
    With these samples, the tests are then carried out in thromboelastometrie/thromboelastography. In addition standard laboratory tests will be made.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Changes in ROTEM-variables in EXTEM, NATEM, ECATEM und FIBTEM in comparison to blood samples without Rivaroxaban/Dabigatran

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Secondary Outcome

Changes in ROTEM-variables ECATEM and diluted tissue factor test with and without substance specific catcher.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/09/01
  •   30
  •   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

1. Written consent
2. Age >18 years

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Exclusion Criteria

1. Myelodysplastic syndrome
2. Thrombopenia
3. Hereditary coagulation diseases

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Addresses

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    • Klinik für AnästhesiologieKlinikum der Universität MünchenLudwig-Maximilians-Universität
    • Mr.  Priv.-Doz. Dr. med.  Simon  Schäfer 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik für AnästhesiologieKlinikum der Universität MünchenLudwig-Maximilians-Universität
    • Mr.  Priv.-Doz. Dr. med.  Simon  Schäfer 
    • Marchioninistr. 15
    • 81377  München
    • Germany
    end of 1:1-Block address scientific-contact
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    • Klinik für AnästhesiologieKlinikum der Universität MünchenLudwig-Maximilians-Universität
    • Mr.  Priv.-Doz. Dr. med.  Simon  Schäfer 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Tem International GmbH
    • Martin-Kollar-Straße 13
    • 81829  München
    • 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.