<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/NCT02200692</url>
  </required_header>
  <id_info>
    <org_study_id>2014/607</org_study_id>
    <secondary_id>REK 2014/607</secondary_id>
    <nct_id>NCT02200692</nct_id>
  </id_info>
  <brief_title>Allergic Transfusion Reactions in Plasma Transfusion</brief_title>
  <official_title>Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Allergic transfusion reactions are a common complication of transfusion by blood components&#xD;
      containing plasma. This study aims to investigate passive transfer of Immunoglobin E&#xD;
      antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent&#xD;
      Detergent plasma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and&#xD;
      other factors associated with allergic complications in patients receiving plasma&#xD;
      transfusion. Samples from patients and plasma units will be investigated. Samples frozen&#xD;
      until investigation. To assess biological relevance of findings, additional analysis of&#xD;
      basophil reactivity will be performed and information on clinical allergy collected by use of&#xD;
      a questionaire .&#xD;
&#xD;
      In-patients will be recruited if receiving plasma transfusion during surgery or if an&#xD;
      allergic transfusion complication occurs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Change from baseline in concentration of allergen specific Immunoglobin E antibodies</measure>
    <time_frame>Baseline and up to 8 weeks</time_frame>
    <description>Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated daily during hospital stay (anticipated up to 14 days), and 4, 6 and/or 8 weeks after transfusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in basophil reactivity measured by flow cytometry</measure>
    <time_frame>Baseline and up to 8 weeks</time_frame>
    <description>Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated during hospital stay, and 4, 6 and/or 8 weeks after transfusion.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of patients with Serious and Non-Serious Adverse Events</measure>
    <time_frame>Up to 8 weeks after transfusion</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>Allergy</condition>
  <condition>Transfusion Reaction</condition>
  <arm_group>
    <arm_group_label>plasma transfusion</arm_group_label>
    <description>Patients receiving plasma transfusion.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples from patients receiving plasma transfusion and samples from plasma units transfused.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving plasma transfusion, mainly in relation to cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving plasma transfusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients not able to complete sampling procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torunn O Apelseth, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helse Bergen HF, Haukeland University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>N-5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>plasma transfusion</keyword>
  <keyword>allergic transfusion reaction</keyword>
  <keyword>transfusion reaction</keyword>
  <keyword>blood transfusion</keyword>
  <keyword>Solvent detergent plasma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Transfusion Reaction</mesh_term>
  </condition_browse>
  <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/NCT02200692
org study id: 2014/607
secondary id: REK 2014/607
nct id: NCT02200692
lead sponsor: 
has dmc: No
Allergic transfusion reactions are a common complication of transfusion by blood components
      containing plasma. This study aims to investigate passive transfer of Immunoglobin E
      antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent
      Detergent plasma.
Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and
      other factors associated with allergic complications in patients receiving plasma
      transfusion. Samples from patients and plasma units will be investigated. Samples frozen
      until investigation. To assess biological relevance of findings, additional analysis of
      basophil reactivity will be performed and information on clinical allergy collected by use of
      a questionaire .

      In-patients will be recruited if receiving plasma transfusion during surgery or if an
      allergic transfusion complication occurs.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in concentration of allergen specific Immunoglobin E antibodies
time frame: Baseline and up to 8 weeks
description: Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated daily during hospital stay (anticipated up to 14 days), and 4, 6 and/or 8 weeks after transfusion.
measure: Change from baseline in basophil reactivity measured by flow cytometry
time frame: Baseline and up to 8 weeks
description: Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated during hospital stay, and 4, 6 and/or 8 weeks after transfusion.
measure: Number of patients with Serious and Non-Serious Adverse Events
time frame: Up to 8 weeks after transfusion
arm group label: plasma transfusion
description: Patients receiving plasma transfusion.
Samples from patients receiving plasma transfusion and samples from plasma units transfused.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Torunn O Apelseth, MD, PhD
role: Principal Investigator
affiliation: Helse Bergen HF, Haukeland University Hospital
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Transfusion Reaction
sharing ipd: No