xml: <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/NCT06019364</url>
    </required_header>
    <id_info>
      <org_study_id>280695</org_study_id>
      <nct_id>NCT06019364</nct_id>
    </id_info>
    <brief_title>Transfusion of Whole Blood in Acute Bleeding</brief_title>
    <acronym>HEPEP</acronym>
    <official_title>Transfusion av Helblod - Egenskaper Hos Produkten Och Effekt av Transfusion Hos Patienter</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sofia Ramström</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Örebro University, Sweden</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>
        Blood collected from blood donors is routinely divided into its different components, red&#xD;
        blood cells, plasma and platelets. These components are stored under different storage&#xD;
        conditions and their maximum storage time before transfusion is different. Platelets are&#xD;
        stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function.&#xD;
  &#xD;
        Research has been conduction on blood stored and transfused as whole blood (without&#xD;
        separation into the various components), particularly in situations of acute trauma. Region&#xD;
        Örebro län will therefore start transfusion of whole blood in such situations. The whole&#xD;
        blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets&#xD;
        will be stored at a lower temperature than standard and for a longer time period. The&#xD;
        research on how this will affect platelet function is limited.&#xD;
  &#xD;
        This project aims to determine how the patients are affected regarding coagulation,&#xD;
        hemolysis, renal function, immunisation, transfusion reactions and the effect of substances&#xD;
        released from the blood cells in the whole blood units during the storage period and if there&#xD;
        is an impact on mortality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Blood collected from blood donors is routinely divided into its different components, red&#xD;
        blood cells, plasma and platelets. These components are stored under different storage&#xD;
        conditions and their maximum storage time before transfusion is different. Platelets are&#xD;
        stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function.&#xD;
  &#xD;
        Platelets function is to contribute to the formation of a clot to stop and prevent bleeding.&#xD;
        Previous studies has shown that this might be affected if they are stored refrigerated.&#xD;
        Exactly how they are affected is not known and when this occurs during the storage period.&#xD;
  &#xD;
        Research has been conduction on blood stored and transfused as whole blood (without&#xD;
        separation into the various components), particularly in situations of acute trauma. Region&#xD;
        Örebro län will therefore start transfusion of whole blood in such situations. The whole&#xD;
        blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets&#xD;
        will be stored at a lower temperature than standard and for a longer time period. The&#xD;
        research on how this will affect platelet function is limited.&#xD;
  &#xD;
        Since transfusion of refrigerated whole blood is a new procedure this project aims to&#xD;
        determine how the patients are affected regarding coagulation, hemolysis, renal function,&#xD;
        immunisation, transfusion reactions and the effect of substances released from the blood&#xD;
        cells in the whole blood units during the storage period and if there is an impact on&#xD;
        mortality.&#xD;
  &#xD;
        Patients requiring transfusion with a whole blood due to an acute situation with bleeding&#xD;
        will be enrolled. Blood samples will be taken from the patients for analysis directly before&#xD;
        the transfusion and at various time points after the transfusion. Clinical variables of&#xD;
        importance to interpret the effect of the whole blood transfusion will be registered as well&#xD;
        as basic information such as sex, age, height, weight, blood group and type of injury causing&#xD;
        the bleeding, treatment etc.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2031</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2030</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>Mortality</measure>
      <time_frame>30 day mortality</time_frame>
      <description>Death within 30 days following the transfusion of whole blood</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effect of the whole blood transfusion on coagulation</measure>
      <time_frame>All transfusions occuring within 24 hours post transfusion of the whole blood unit</time_frame>
      <description>Requirement for other transfusions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bleeding</measure>
      <time_frame>All transfusions occuring within 24 hours post transfusion of the whole blood unit</time_frame>
      <description>Bleeding following transfusion of the whole blood unit</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hemolysis</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30</time_frame>
      <description>Hemolysis at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Platelet count</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30</time_frame>
      <description>Platelet count at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Red blood cell count</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30</time_frame>
      <description>Red blood cell count at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>APTT, a marker of coagulation capacity</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of APTT at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PT, a marker of coagulation capacity</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of PT at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-thrombin, a marker of coagulation capacity</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of anti-thrombin at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibrinogen, a marker of of coagulation capacity</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of fibrinogen at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Electrolytes</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Electrolytes at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creatinine, a marker of of renal function</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of Creatinine at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GFR, a marker of renal function</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of GFR at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urea, a measure of renal function</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of urea at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sP-selectin, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of sP-selectin at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PF4, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of PF4 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MMP9, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of MMP9 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sCD40L, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of sCD40L at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sGPV, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of sGPV at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sGPVI, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of sGPVI at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SCUBE1, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of SCUBE1 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TSP1, a soluble marker of platelet activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of TSP1 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CRP, a marker of inflammation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of CRP at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum amyloid A (SAA), a marker of inflammation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of Serum amyloid A at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sTNFR1, a marker of inflammation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of sTNFR1 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sTNFR2, a marker of inflammation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of sTNFR2 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>D-dimer, a marker of coagulation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of D-dimer at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>vWF, a marker of coagulation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of vWF at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TAT, a marker of coagulation activation</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of TAT at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RANTES, a bio modulating substance</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of RANTES at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VEGF, a bio modulating substance</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of VEGF at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IFN-gamma, a bio modulating substance</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of IFN-gamma at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNF-alfa, a bio modulating substance</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of TNF-alfa at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IL-7, a bio modulating substance</measure>
      <time_frame>Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30</time_frame>
      <description>Analysis of IL-7 at various time points in conjunction to the whole blood transfusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunisation</measure>
      <time_frame>Within 30 days post transfusion</time_frame>
      <description>Occurence of immunisation following transfusion of the whole blood</description>
    </secondary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Blood Transfusion</condition>
    <condition>Acute Bleeding</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole blood transfusion</intervention_name>
      <description>Transfusion of whole blood in a situation with acute bleeding according to routine practice.</description>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Samples without DNA retained from the patient (plasma and serum)&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with acute bleeding that are transfused with whole blood at the time of the acute&#xD;
          bleeding episode.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with acute bleeding&#xD;
  &#xD;
            -  Transfused with whole blood at the time of the acute bleeding episode&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients where vital information lacking needed to interpret data (i.e. blood cell&#xD;
               count)&#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_official>
      <last_name>Sofia Ramström, Ass. Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Örebro University, Sweden</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Örebro University</name>
        <address>
          <city>Örebro</city>
          <zip>70182</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Örebro University, Sweden</investigator_affiliation>
      <investigator_full_name>Sofia Ramström</investigator_full_name>
      <investigator_title>Associated Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019364
  org study id: 280695
  nct id: NCT06019364
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Blood collected from blood donors is routinely divided into its different components, red
        blood cells, plasma and platelets. These components are stored under different storage
        conditions and their maximum storage time before transfusion is different. Platelets are
        stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function.
  
        Research has been conduction on blood stored and transfused as whole blood (without
        separation into the various components), particularly in situations of acute trauma. Region
        Örebro län will therefore start transfusion of whole blood in such situations. The whole
        blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets
        will be stored at a lower temperature than standard and for a longer time period. The
        research on how this will affect platelet function is limited.
  
        This project aims to determine how the patients are affected regarding coagulation,
        hemolysis, renal function, immunisation, transfusion reactions and the effect of substances
        released from the blood cells in the whole blood units during the storage period and if there
        is an impact on mortality.
  Blood collected from blood donors is routinely divided into its different components, red
        blood cells, plasma and platelets. These components are stored under different storage
        conditions and their maximum storage time before transfusion is different. Platelets are
        stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function.
  
        Platelets function is to contribute to the formation of a clot to stop and prevent bleeding.
        Previous studies has shown that this might be affected if they are stored refrigerated.
        Exactly how they are affected is not known and when this occurs during the storage period.
  
        Research has been conduction on blood stored and transfused as whole blood (without
        separation into the various components), particularly in situations of acute trauma. Region
        Örebro län will therefore start transfusion of whole blood in such situations. The whole
        blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets
        will be stored at a lower temperature than standard and for a longer time period. The
        research on how this will affect platelet function is limited.
  
        Since transfusion of refrigerated whole blood is a new procedure this project aims to
        determine how the patients are affected regarding coagulation, hemolysis, renal function,
        immunisation, transfusion reactions and the effect of substances released from the blood
        cells in the whole blood units during the storage period and if there is an impact on
        mortality.
  
        Patients requiring transfusion with a whole blood due to an acute situation with bleeding
        will be enrolled. Blood samples will be taken from the patients for analysis directly before
        the transfusion and at various time points after the transfusion. Clinical variables of
        importance to interpret the effect of the whole blood transfusion will be registered as well
        as basic information such as sex, age, height, weight, blood group and type of injury causing
        the bleeding, treatment etc.
  observational model: Cohort
  time perspective: Prospective
  measure: Mortality
  time frame: 30 day mortality
  description: Death within 30 days following the transfusion of whole blood
  measure: Effect of the whole blood transfusion on coagulation
  time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit
  description: Requirement for other transfusions
  measure: Bleeding
  time frame: All transfusions occuring within 24 hours post transfusion of the whole blood unit
  description: Bleeding following transfusion of the whole blood unit
  measure: Hemolysis
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
  description: Hemolysis at various time points in conjunction to the whole blood transfusion
  measure: Platelet count
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
  description: Platelet count at various time points in conjunction to the whole blood transfusion
  measure: Red blood cell count
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30
  description: Red blood cell count at various time points in conjunction to the whole blood transfusion
  measure: APTT, a marker of coagulation capacity
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of APTT at various time points in conjunction to the whole blood transfusion
  measure: PT, a marker of coagulation capacity
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of PT at various time points in conjunction to the whole blood transfusion
  measure: Anti-thrombin, a marker of coagulation capacity
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of anti-thrombin at various time points in conjunction to the whole blood transfusion
  measure: Fibrinogen, a marker of of coagulation capacity
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of fibrinogen at various time points in conjunction to the whole blood transfusion
  measure: Electrolytes
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Electrolytes at various time points in conjunction to the whole blood transfusion
  measure: Creatinine, a marker of of renal function
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of Creatinine at various time points in conjunction to the whole blood transfusion
  measure: GFR, a marker of renal function
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of GFR at various time points in conjunction to the whole blood transfusion
  measure: Urea, a measure of renal function
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of urea at various time points in conjunction to the whole blood transfusion
  measure: sP-selectin, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of sP-selectin at various time points in conjunction to the whole blood transfusion
  measure: PF4, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of PF4 at various time points in conjunction to the whole blood transfusion
  measure: MMP9, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of MMP9 at various time points in conjunction to the whole blood transfusion
  measure: sCD40L, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of sCD40L at various time points in conjunction to the whole blood transfusion
  measure: sGPV, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of sGPV at various time points in conjunction to the whole blood transfusion
  measure: sGPVI, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of sGPVI at various time points in conjunction to the whole blood transfusion
  measure: SCUBE1, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of SCUBE1 at various time points in conjunction to the whole blood transfusion
  measure: TSP1, a soluble marker of platelet activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of TSP1 at various time points in conjunction to the whole blood transfusion
  measure: CRP, a marker of inflammation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of CRP at various time points in conjunction to the whole blood transfusion
  measure: Serum amyloid A (SAA), a marker of inflammation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of Serum amyloid A at various time points in conjunction to the whole blood transfusion
  measure: sTNFR1, a marker of inflammation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of sTNFR1 at various time points in conjunction to the whole blood transfusion
  measure: sTNFR2, a marker of inflammation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of sTNFR2 at various time points in conjunction to the whole blood transfusion
  measure: D-dimer, a marker of coagulation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of D-dimer at various time points in conjunction to the whole blood transfusion
  measure: vWF, a marker of coagulation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of vWF at various time points in conjunction to the whole blood transfusion
  measure: TAT, a marker of coagulation activation
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of TAT at various time points in conjunction to the whole blood transfusion
  measure: RANTES, a bio modulating substance
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of RANTES at various time points in conjunction to the whole blood transfusion
  measure: VEGF, a bio modulating substance
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of VEGF at various time points in conjunction to the whole blood transfusion
  measure: IFN-gamma, a bio modulating substance
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of IFN-gamma at various time points in conjunction to the whole blood transfusion
  measure: TNF-alfa, a bio modulating substance
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of TNF-alfa at various time points in conjunction to the whole blood transfusion
  measure: IL-7, a bio modulating substance
  time frame: Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30
  description: Analysis of IL-7 at various time points in conjunction to the whole blood transfusion
  measure: Immunisation
  time frame: Within 30 days post transfusion
  description: Occurence of immunisation following transfusion of the whole blood
  intervention type: Other
  intervention name: Whole blood transfusion
  description: Transfusion of whole blood in a situation with acute bleeding according to routine practice.
  Samples without DNA retained from the patient (plasma and serum)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sofia Ramström, Ass. Prof
  role: Principal Investigator
  affiliation: Örebro University, Sweden
  facility: 
  country: Sweden
  responsible party type: Sponsor-Investigator
  investigator affiliation: Örebro University, Sweden
  investigator full name: Sofia Ramström
  investigator title: Associated Professor
  mesh term: Hemorrhage
  sharing ipd: No