Trial document




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  DRKS00015302

Trial Description

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Title

Detection of direct oral anticoagulants with ClotPro

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The present study aims to investigate current anticoagulants with new test methods (ClotPro). So far, it is only indirectly and hardly possible to detect the new blood thinners through rapid laboratory tests.
The goal should be to better recognize them in emergency situations and thus to be able to offer better therapy. These emergencies include acute injuries with bleeding.
On the one hand, healthy volunteers are included in order to make comparative tests in the laboratory.
Thereafter, blood samples from neurological patients are examined at several times. These are patients who, after a stroke or similar illness, are being hired for the first time to use anticoagulants of the new generation. Here blood samples are to be examined at the time of maximum effective levels and at the minimum level of effect. On the other Hand patients with stable intake are evaluated (one blood withdrawal).
The aim is to prove the safe function of the tests.

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Brief Summary in Scientific Language

The new oral anticoagulants dabigatran, edoxaban and rivaroxaban as well as marcumar and heparin are to be investigated by means of rotational thrombelastometry (ClotPro). 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 ClotPro or Standard laboratory testssamples resinated with rivaroxaban or dabigatran.
Evaluation in daily routine includes neurological patients with intake of one of the anticoagulants for the first time in their medication (for example after a stroke) or with stable intake.
Blood samples will be evaluated at different times (before first medication, after 2 hours, just before the second medication) and once in patients with stable intake.
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.

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Organizational Data

  •   DRKS00015302
  •   2018/08/27
  •   [---]*
  •   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, edoxaban and rivaroxaban, as well as marcumar and heparin are to be investigated by rotation thrombelastometry / graphy (ClotPro). 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, on the one hand, stroke patients newly adjusted to one of the anticoagulants and stable patients. 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. Every time 10ml of blood will be taken. In the case of stable patients, blood (10 ml) is taken once.
    The aim is to evaluate the new tests in thrombelastomeytria / thrombelastography in everyday clinical practice and to be able to detect the new oral anticoagulants in case of unclear, unquenchable bleeding in the future.
  •   For the preparation and evaluation of the tests, first in vitro preliminary tests are carried out.
    For this purpose, blood from healthy volunteers (20 ml) is mixed with the active substances according to different levels of effect (peak level, trough level, maximum effective level, twice the effective level).
    These samples are then used in thrombelasytometry / thrombelastography assays. In addition, the standard laboratory tests are carried out.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Change in specific tests ECATEST® and RVV® in contrast to blood samples without direct oral anticoagulant (doac).

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Secondary Outcome

Change in universal tests EXTEST and INTEST in contrast to blood samples without doac.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/09/01
  •   70
  •   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
Intake of anticoagulation
Informed consent

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Exclusion Criteria

Age < 18 years
Coagulation disorder
Refusal of the patient

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Addresses

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    • Klinik für Anästhesiologie, Klinikum der Universität München, LMU München
    • Mr.  PD. Dr. med.  Simon  Schäfer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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    • Klinik für Anästhesiologie, Klinikum der Universität München, LMU München
    • Mr.  PD. Dr. med.  Simon  Schäfer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
    end of 1:1-Block address scientific-contact
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    • Klinik für Anästhesiologie, Klinikum der Universität München, LMU München
    • Mr.  PD. Dr. med.  Simon  Schäfer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie, Klinikum der Universität München, LMU München
    • Mr.  PD. Dr. med.  Simon  Schäfer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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    • Dynabyte GmbH
    • Reichenbachstr. 27
    • 80469  München
    • Germany
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Status

  •   Recruiting planned
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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.