<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/NCT03242525</url>
  </required_header>
  <id_info>
    <org_study_id>279/17</org_study_id>
    <nct_id>NCT03242525</nct_id>
  </id_info>
  <brief_title>Examination of the Time Advantage Between POCT and Conventional Central Laboratory Analysis</brief_title>
  <official_title>Examination of the Time Advantage of Point of Care Testing (POCT) Compared to the Conventional Central Laboratory Analysis in Intraclinical Patient Care</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to quantify the time advantage achieved by the use of POCT&#xD;
      compared to conventional coagulation diagnostics. A further objective of this study is an&#xD;
      analysis of the result quality of POCT for the prothrombin time / international normalized&#xD;
      ratio.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to be able to carry out a targeted coagulation therapy for the time-critical&#xD;
      treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is&#xD;
      necessary.&#xD;
&#xD;
      After taking blood samples for coagulation diagnostics, they are sent to the central&#xD;
      laboratory. After the analysis and validation the electronic provision of the results takes&#xD;
      place. The loss of time by sample transport, analysis and breadth of the results extends the&#xD;
      duration until therapy can be started.&#xD;
&#xD;
      The period of time until these analysis results are determined depends on several factors&#xD;
      like daytime, day of week and location of the sample consignor and the availability of the&#xD;
      laboratory. Not every clinic is connected to an internal tube mail system so that the samples&#xD;
      have to be sent partly with a transport service.&#xD;
&#xD;
      In recent years, Point of Care (POCT) devices have become an increasingly important tool for&#xD;
      diagnosing coagulopathic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>
  <primary_outcome>
    <measure>Time advantage</measure>
    <time_frame>2-4 hours</time_frame>
    <description>Duration until laboratory results are available after sampling for central laboratory versus POCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between central laboratory and POCT results.</measure>
    <time_frame>2-4 hours</time_frame>
    <description>Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of transport type.</measure>
    <time_frame>2-4 hours</time_frame>
    <description>Difference of results availability weather probes are transported by transport service or tube-mail.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of daytime and weekday on results availability.</measure>
    <time_frame>2-4 hours</time_frame>
    <description>Difference of results availability in dependence of daytime and weekday on transport duration.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Blood</condition>
  <condition>Point-of-Care Systems</condition>
  <condition>Analysis, Event History</condition>
  <arm_group>
    <arm_group_label>Emergency room</arm_group_label>
    <description>Twelve bleeding patients who are assigned to the emergency department receive a simultaneous blood analysis with POCT and central laboratory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delivery room</arm_group_label>
    <description>Twelve bleeding patients who are assigned to the delivery room receive a simultaneous blood analysis with POCT and central laboratory.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>POCT and central laboratory blood analysis</intervention_name>
    <description>In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.</description>
    <arm_group_label>Delivery room</arm_group_label>
    <arm_group_label>Emergency room</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All bleeding patients assigned to the emergency department and delivery room.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing written consent&#xD;
&#xD;
          -  Withdrawal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kai Zacharowski, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anesthesia, Intensive Care Medicine and Pain Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>March 17, 2019</last_update_submitted>
  <last_update_submitted_qc>March 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</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. med. Florian Raimann</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03242525
org study id: 279/17
nct id: NCT03242525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to quantify the time advantage achieved by the use of POCT
      compared to conventional coagulation diagnostics. A further objective of this study is an
      analysis of the result quality of POCT for the prothrombin time / international normalized
      ratio.
In order to be able to carry out a targeted coagulation therapy for the time-critical
      treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is
      necessary.

      After taking blood samples for coagulation diagnostics, they are sent to the central
      laboratory. After the analysis and validation the electronic provision of the results takes
      place. The loss of time by sample transport, analysis and breadth of the results extends the
      duration until therapy can be started.

      The period of time until these analysis results are determined depends on several factors
      like daytime, day of week and location of the sample consignor and the availability of the
      laboratory. Not every clinic is connected to an internal tube mail system so that the samples
      have to be sent partly with a transport service.

      In recent years, Point of Care (POCT) devices have become an increasingly important tool for
      diagnosing coagulopathic patients.
observational model: Case-Control
time perspective: Prospective
measure: Time advantage
time frame: 2-4 hours
description: Duration until laboratory results are available after sampling for central laboratory versus POCT
measure: Correlation between central laboratory and POCT results.
time frame: 2-4 hours
description: Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.
measure: Influence of transport type.
time frame: 2-4 hours
description: Difference of results availability weather probes are transported by transport service or tube-mail.
measure: Influence of daytime and weekday on results availability.
time frame: 2-4 hours
description: Difference of results availability in dependence of daytime and weekday on transport duration.
arm group label: Emergency room
description: Twelve bleeding patients who are assigned to the emergency department receive a simultaneous blood analysis with POCT and central laboratory.
arm group label: Delivery room
description: Twelve bleeding patients who are assigned to the delivery room receive a simultaneous blood analysis with POCT and central laboratory.
intervention type: Diagnostic Test
intervention name: POCT and central laboratory blood analysis
description: In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.
arm group label: Delivery room
arm group label: Emergency room
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kai Zacharowski, Prof. Dr.
role: Study Director
affiliation: Department of Anesthesia, Intensive Care Medicine and Pain Therapy
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Dr. med. Florian Raimann
investigator title: Dr. med.
sharing ipd: No