<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/NCT03754868</url>
  </required_header>
  <id_info>
    <org_study_id>19/5/13</org_study_id>
    <nct_id>NCT03754868</nct_id>
  </id_info>
  <brief_title>Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy</brief_title>
  <official_title>Analysis of the Activity of Different Coagulation Factors and Monitoring of Coagulation Using Point-of-care Devices During a Veno-venous ECMO Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Goettingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Goettingen</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>
      Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim&#xD;
      of this study is to provide a detailed analysis of the activity of different coagulation&#xD;
      factors and changes in functional coagulation measurements as in rotational thrombelastometry&#xD;
      and multiple electrode aggregometry in the course of ECMO therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor V [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor X [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>vWF-Antigen</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Measurement of the vWF-Antigen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy</measure>
    <time_frame>Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation</time_frame>
    <description>Repeated assessments of the vWF:Ristocetin-Cofaktor-Activity [%]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CT-EXTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clotting time (CT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CT-INTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clotting time (CT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CT-FIBTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clotting time (CT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CT-HEPTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clotting time (CT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CFT-EXTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clot formation time (CFT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CFT-INTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clot formation time (CFT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CFT-FIBTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clot formation time (CFT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CFT-HEPTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in clot formation time (CFT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MCF-EXTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in maximum clot firmness (MCF) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MCF-INTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in maximum clot firmness (MCF) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MCF-FIBTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in maximum clot firmness (MCF) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MCF-HEPTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in maximum clot firmness (MCF) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Alpha angle-EXTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in Alpha angle in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Alpha angle-INTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in Alpha angle in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Alpha angle-FIBTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in Alpha angle in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Alpha angle-HEPTEM</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Changes in Alpha angle in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in degree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Platelet aggregation after stimulation with arachidonic acid was recorded in aggregational units (AU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Platelet aggregation after stimulation with ADP was recorded in aggregational units (AU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation</time_frame>
    <description>Platelet aggregation after stimulation with TRAP was recorded in aggregational units (AU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Light transmission aggregometry</measure>
    <time_frame>6 hours and 7 days after canulation</time_frame>
    <description>Measurement of platelet function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quick</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>Measurement of Quick in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activated partial thromboplastin time (aPTT)</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>Measurement of aPTT in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>Measurement of fibrinogen concentration in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet count</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>Measurement of platelet count/µl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activated clotting time (ACT)</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>Measurement of ACT in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antithrombin III (ATIII)</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>Measurement of ATIII in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Anti-Xa-Activity in %</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation</time_frame>
    <description>Measurement of Anti-Xa-Activity by chromogenic assay to determine heparin effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-Dimers</measure>
    <time_frame>Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation</time_frame>
    <description>Measurement of D-Dimers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>hemoglobin concentration in g/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>leucocyte count</measure>
    <time_frame>Pre-canulation, 6 hours and daily from day 1- day 21after canulation</time_frame>
    <description>leucocyte count/µl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemorrhagic complications</measure>
    <time_frame>Daily from day 1-21</time_frame>
    <description>Structured documentation of hemorrhagic complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombotic complications</measure>
    <time_frame>Daily from day 1-21</time_frame>
    <description>Structured documentation of thrombotic complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenator State</measure>
    <time_frame>Daily from day 1-21</time_frame>
    <description>Structured documentation of the state of the oxygenator including search for thrombotic material</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Extracorporeal Membrane Oxygenation Complication</condition>
  <condition>Coagulation Factor Deficiency</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Detailed coagulation monitoring</intervention_name>
    <description>Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care&#xD;
        unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Need for a Veno-venous extracorporeal membrane oxygenation therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known coagulation disorders&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Onnen Moerer, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, University Medical Center Goettingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Goettingen</name>
      <address>
        <city>Goettingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Goettingen</investigator_affiliation>
    <investigator_full_name>Saskia Wand</investigator_full_name>
    <investigator_title>Resident for Anesthesiology, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ECMO</keyword>
  <keyword>Coagulation monitoring</keyword>
  <keyword>point-of-care</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03754868
org study id: 19/5/13
nct id: NCT03754868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim
      of this study is to provide a detailed analysis of the activity of different coagulation
      factors and changes in functional coagulation measurements as in rotational thrombelastometry
      and multiple electrode aggregometry in the course of ECMO therapy.
observational model: Cohort
time perspective: Prospective
measure: Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor V [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor X [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.
measure: Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.
measure: vWF-Antigen
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Measurement of the vWF-Antigen
measure: Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy
time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
description: Repeated assessments of the vWF:Ristocetin-Cofaktor-Activity [%]
measure: Changes in CT-EXTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clotting time (CT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
measure: Changes in CT-INTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clotting time (CT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
measure: Changes in CT-FIBTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clotting time (CT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.
measure: Changes in CT-HEPTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clotting time (CT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.
measure: Changes in CFT-EXTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clot formation time (CFT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
measure: Changes in CFT-INTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clot formation time (CFT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
measure: Changes in CFT-FIBTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clot formation time (CFT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.
measure: Changes in CFT-HEPTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in clot formation time (CFT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.
measure: Changes in MCF-EXTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in maximum clot firmness (MCF) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
measure: Changes in MCF-INTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in maximum clot firmness (MCF) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
measure: Changes in MCF-FIBTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in maximum clot firmness (MCF) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in millimeters.
measure: Changes in MCF-HEPTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in maximum clot firmness (MCF) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in millimeters.
measure: Changes in Alpha angle-EXTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in Alpha angle in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
measure: Changes in Alpha angle-INTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in Alpha angle in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
measure: Changes in Alpha angle-FIBTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in Alpha angle in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in degree.
measure: Changes in Alpha angle-HEPTEM
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Changes in Alpha angle in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in degree.
measure: Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Platelet aggregation after stimulation with arachidonic acid was recorded in aggregational units (AU).
measure: Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Platelet aggregation after stimulation with ADP was recorded in aggregational units (AU).
measure: Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
description: Platelet aggregation after stimulation with TRAP was recorded in aggregational units (AU).
measure: Light transmission aggregometry
time frame: 6 hours and 7 days after canulation
description: Measurement of platelet function
measure: Quick
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: Measurement of Quick in %
measure: activated partial thromboplastin time (aPTT)
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: Measurement of aPTT in seconds
measure: Fibrinogen
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: Measurement of fibrinogen concentration in mg/dl
measure: Platelet count
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: Measurement of platelet count/µl
measure: activated clotting time (ACT)
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: Measurement of ACT in seconds
measure: Antithrombin III (ATIII)
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: Measurement of ATIII in %
measure: Measurement of Anti-Xa-Activity in %
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
description: Measurement of Anti-Xa-Activity by chromogenic assay to determine heparin effect
measure: D-Dimers
time frame: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
description: Measurement of D-Dimers
measure: hemoglobin
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: hemoglobin concentration in g/dl
measure: leucocyte count
time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
description: leucocyte count/µl
measure: Hemorrhagic complications
time frame: Daily from day 1-21
description: Structured documentation of hemorrhagic complications
measure: Thrombotic complications
time frame: Daily from day 1-21
description: Structured documentation of thrombotic complications
measure: Oxygenator State
time frame: Daily from day 1-21
description: Structured documentation of the state of the oxygenator including search for thrombotic material
intervention type: Diagnostic Test
intervention name: Detailed coagulation monitoring
description: Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Onnen Moerer, Prof.
role: Principal Investigator
affiliation: Department of Anesthesiology, University Medical Center Goettingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Goettingen
investigator full name: Saskia Wand
investigator title: Resident for Anesthesiology, Principal Investigator
sharing ipd: Undecided