<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01704053</url>
  </required_header>
  <id_info>
    <org_study_id>NOAPOC-271/12</org_study_id>
    <nct_id>NCT01704053</nct_id>
  </id_info>
  <brief_title>Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study</brief_title>
  <official_title>Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is determine whether point of care coagulation testing is able to&#xD;
      map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used&#xD;
      as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer&#xD;
      (Multiplate).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will&#xD;
      be taken twice in correlation to the time of drug intake (before and 3 hours after drug&#xD;
      intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer&#xD;
      will be compared directly with the concentrations determined by plasma concentration assays.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">34</enrollment>
  <condition>Clot Formation and Platelet Aggregation in Point of Care Testing</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran&#xD;
        or Rivaroxaban for prevention of stroke and systemic embolism.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving Dabigatran or Rivaroxaban&#xD;
&#xD;
          -  Adults &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving concomittantly inhibitors of platelet function&#xD;
&#xD;
          -  Renal insufficiency (Creatinine &gt; 1,5 mg/dl), Urea &gt; 80 mg/dl)&#xD;
&#xD;
          -  Hemodialysis&#xD;
&#xD;
          -  Hepatic Dysfunction (AST &gt; 30 U/l, ALT &gt; 30 U/l)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy</name>
      <address>
        <city>Frankfurt/Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Matthias Klages</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>New Oral Anticoagulants</keyword>
  <keyword>Dabigatran</keyword>
  <keyword>Rivaroxaban</keyword>
  <keyword>Thrombelastometry/-graphy (ROTEM, TEG)</keyword>
  <keyword>Multiple Platelet Function Analyzer (Multiplate)</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704053
org study id: NOAPOC-271/12
nct id: NCT01704053
lead sponsor: 
has dmc: Yes
The purpose of this study is determine whether point of care coagulation testing is able to
      map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used
      as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer
      (Multiplate).
Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will
      be taken twice in correlation to the time of drug intake (before and 3 hours after drug
      intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer
      will be compared directly with the concentrations determined by plasma concentration assays.
observational model: Case-Control
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Dr. Matthias Klages
investigator title: M.D.