<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/NCT01727830</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2012-0042</org_study_id>
    <nct_id>NCT01727830</nct_id>
  </id_info>
  <brief_title>Hemodilution and Coagulopathy With 3 Colloids</brief_title>
  <official_title>Influence of Hemodilution on Coagulation, pH, Platelet Function, Laboratory Values and ROTEM in Volunteers Using HES 6%, Gelatine and Balanced Gelatine and the Reversal of Coagulopathy With F XIII and Fibrinogen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution&#xD;
      with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate&#xD;
      reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination&#xD;
      of FBG and FXIII.&#xD;
&#xD;
      In blood of 12 volunteers the following measurements are performed at baseline and 60%&#xD;
      dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation&#xD;
      factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational&#xD;
      thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in&#xD;
      concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and&#xD;
      determination of factor concentrations are again performed.&#xD;
&#xD;
        -  Trial with medical device&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Reversibility of in vitro induced coagulopathy</measure>
    <time_frame>Same day when blood was drawn</time_frame>
    <description>Coagulopathy in vitro measured after 60 % dilution with HES, Gelatin and Gelatin balanced. Addition of fibrinogen and factor XIII as well as their combination and measurement if the coagulopathy was corrected.</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Dilutional Coagulopathy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)</intervention_name>
    <description>Blood drawn from volunteers</description>
    <other_name>This trial is in vitro and made with blood of healthy volunteers.</other_name>
    <other_name>Thus no drug no intervention beside drawing blood is beeing performed.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  signed informed consent from before blood withdrawal&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  known coagulation disorders,&#xD;
&#xD;
          -  any form of anticoagulation therapy,&#xD;
&#xD;
          -  use of acetyl-salicylic acid within the past five days,&#xD;
&#xD;
          -  use of non-steroidal anti-inflammatory agents within the past 24 hours,&#xD;
&#xD;
          -  known renal disease or plasma concentrations of aspartate aminotransferase (&gt;50 U l&#xD;
             -1) or alanine aminotransferase (&gt;50 U l-1)&#xD;
&#xD;
          -  patients incapable of understanding the German language&#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>Oliver Theusinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Anaesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Anaesthesiology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727830
org study id: KEK-ZH-Nr. 2012-0042
nct id: NCT01727830
lead sponsor: 
has dmc: No
Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution
      with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate
      reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination
      of FBG and FXIII.

      In blood of 12 volunteers the following measurements are performed at baseline and 60%
      dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation
      factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational
      thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in
      concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and
      determination of factor concentrations are again performed.

        -  Trial with medical device
observational model: Case-Control
time perspective: Prospective
measure: Reversibility of in vitro induced coagulopathy
time frame: Same day when blood was drawn
description: Coagulopathy in vitro measured after 60 % dilution with HES, Gelatin and Gelatin balanced. Addition of fibrinogen and factor XIII as well as their combination and measurement if the coagulopathy was corrected.
intervention type: Other
intervention name: Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
description: Blood drawn from volunteers
other name: This trial is in vitro and made with blood of healthy volunteers.
other name: Thus no drug no intervention beside drawing blood is beeing performed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Oliver Theusinger, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Anaesthesiology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders