Trial document




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  DRKS00015704

Trial Description

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Title

Detection of anticoagulants with rotational thromboelastometry (ROTEM).

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Trial Acronym

DOAR

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URL of the Trial

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Brief Summary in Lay Language

The present study aims to examine current and old blood thinners with new and old test methods. 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.
Blood samples from stable patients are examined. These are patients who have been treated after a stroke or similar illness. It is once blood taken (20ml).
The aim is to prove the safe function of the tests.

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Brief Summary in Scientific Language

The aim is to investigate the new oral anticoagulants dabigatran, edoxaban, rivaroxaban, apixaban and well-known anticoagulants such as marcumar and heparin by means of rotational thromboelastometry. For this purpose, new tests are available, which are now to be evaluated in everyday clinical practice.
For evaluation in everyday clinical practice, patients should be examined who are already stable on the medication. Blood is taken once and the time of the last dose and duration of administration are examined (20ml). For comparison, 10 healthy volunteers are bled (20 ml) and the appropriate tests are performed.
The aim is to evaluate the new and old tests in rotational thromboelastometry in everyday clinical practice and to be able to detect the new oral anticoagulants in case of unclear, unquenchable bleeding and to be able to establish an actional algorithm in the future. An approval from the ethics committee is available through an amendment to 17-525.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015704
  •   2018/10/05
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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, edoxaban, apixaban and rivaroxaban as well as marcumar are to be investigated by means of rotational thrombelastometry (ROTEM). For this purpose, new tests are available, which are now to be evaluated in everyday clinical practice.
    For evaluation in clinical routine, patients should be examined who are already stably adjusted to the drug. It is taken once blood (20ml).
    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.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Modification of the specific tests Ecatem® and TFtem® compared to blood samples without anticoagulant.

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Secondary Outcome

Change of the known tests EXTEM and INTEM compared to blood samples without anticoagulant.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/15
  •   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.
Approval of the patient.

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Exclusion Criteria

Age < 18 years.
Intake of other anticoagulants.
Known coagulation disorder.
Rejection 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
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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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Status

  •   Recruiting complete, follow-up complete
  •   2019/08/01
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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.