<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/NCT03801135</url>
  </required_header>
  <id_info>
    <org_study_id>MPFhemostaza</org_study_id>
    <nct_id>NCT03801135</nct_id>
  </id_info>
  <brief_title>Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation</brief_title>
  <official_title>A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</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>
      Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure&#xD;
      increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly&#xD;
      because lower fibrinogen levels. The aim of study is to define coagulation status of patient&#xD;
      after plasmapheresis with different laboratory tests and to investigate the possibility of&#xD;
      fibrinogen concentrate replacement for the correction of induced coagulation disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 3, 2018</start_date>
  <completion_date type="Anticipated">September 24, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of plasmapheresis replacement fluid type on fibrinogen level</measure>
    <time_frame>Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]</time_frame>
    <description>Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on coagulation tests after plasmapheresis - ROTEM EXTEM</measure>
    <time_frame>Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]</time_frame>
    <description>ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM</measure>
    <time_frame>Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]</time_frame>
    <description>ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Humoral Rejection</condition>
  <condition>Guillain-Barre Syndrome</condition>
  <condition>Miller Fisher Syndrome</condition>
  <condition>CIDP</condition>
  <condition>Good Pasture Syndrome</condition>
  <condition>Hyperviscosity Syndrome</condition>
  <arm_group>
    <arm_group_label>Electrolyte&amp;Albumin Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibrinogen Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FFP Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fibrinogen concentrate</intervention_name>
    <description>Haemocomplettan will be infused after plasma exchange procedure</description>
    <arm_group_label>Fibrinogen Treatment Group</arm_group_label>
    <other_name>Haemocomplettan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fresh Frozen Plasma</intervention_name>
    <description>Fresh frozen plasma will be part of replacement fluid</description>
    <arm_group_label>FFP Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  Hypertriglyceridemia-induced acute pancreatitis&#xD;
&#xD;
          -  hepatic disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matej Zrimsek</last_name>
    <phone>+38631789714</phone>
    <email>matej.zrimsek@kclj.si</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <state>Gorenjska</state>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matej Zrimsek</last_name>
      <phone>+38631789714</phone>
      <email>matej.zrimsek@kclj.si</email>
    </contact>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Matej Zrimsek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fibrinogen concentrate</keyword>
  <keyword>Fresh frozen plasma</keyword>
  <keyword>ROTEM</keyword>
  <keyword>Fibrinogen</keyword>
  <keyword>Overall coagulation potential</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Glomerular Basement Membrane Disease</mesh_term>
    <mesh_term>Guillain-Barre Syndrome</mesh_term>
    <mesh_term>Miller Fisher Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <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/NCT03801135
org study id: MPFhemostaza
nct id: NCT03801135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure
      increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly
      because lower fibrinogen levels. The aim of study is to define coagulation status of patient
      after plasmapheresis with different laboratory tests and to investigate the possibility of
      fibrinogen concentrate replacement for the correction of induced coagulation disorder.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Effect of plasmapheresis replacement fluid type on fibrinogen level
time frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
description: Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type
measure: Effect on coagulation tests after plasmapheresis - ROTEM EXTEM
time frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
description: ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
measure: Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM
time frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
description: ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
arm group label: Electrolyte&Albumin Group
arm group type: No Intervention
description: One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin.
arm group label: Fibrinogen Treatment Group
arm group type: Experimental
description: One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards.
arm group label: FFP Treatment Group
arm group type: Active Comparator
description: One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.
intervention type: Drug
intervention name: Fibrinogen concentrate
description: Haemocomplettan will be infused after plasma exchange procedure
arm group label: Fibrinogen Treatment Group
other name: Haemocomplettan
intervention type: Other
intervention name: Fresh Frozen Plasma
description: Fresh frozen plasma will be part of replacement fluid
arm group label: FFP Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matej Zrimsek
phone: +38631789714
email: matej.zrimsek@kclj.si
facility: 
status: Recruiting
contact: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Matej Zrimsek
investigator title: Principal Investigator
mesh term: Anti-Glomerular Basement Membrane Disease
mesh term: Guillain-Barre Syndrome
mesh term: Miller Fisher Syndrome
mesh term: Syndrome
sharing ipd: Undecided