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/NCT05985668</url>
    </required_header>
    <id_info>
      <org_study_id>K-2023-0991</org_study_id>
      <nct_id>NCT05985668</nct_id>
    </id_info>
    <brief_title>Towards Improved Diagnostics for Suspected Platelet Function Disorders</brief_title>
    <official_title>Towards Improved Diagnostics for Suspected Platelet Function Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Stockholm</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Region Stockholm</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>
        This study aims to improve platelet function testing during bleeding investigations. To this&#xD;
        end, the study will evaluate the diagnostic accuracy of novel platelet function tests in&#xD;
        patients with confirmed or suspected platelet function disorders. Study participants will be&#xD;
        recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska&#xD;
        University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Platelet-thrombus formation on collagen surface</measure>
      <time_frame>At study inclusion</time_frame>
      <description>Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Platelet count effect on platelet-thrombus formation on collagen surface</measure>
      <time_frame>At study inclusion</time_frame>
      <description>Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count &lt; 150 x 10^9 /L.</description>
    </other_outcome>
    <other_outcome>
      <measure>ddAVP effect on platelet-thrombus formation on collagen surface</measure>
      <time_frame>Immediately before and 1 hour after administration of ddAVP.</time_frame>
      <description>Whole-blood platelet-thrombus formation on collagen surface, similar as for primary outcome measurement. In a subset of patients with a clinical indication (physician discretion).</description>
    </other_outcome>
    <other_outcome>
      <measure>Thrombus formation on collagen/TF</measure>
      <time_frame>At study inclusion</time_frame>
      <description>Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Platelet Function Disorder</condition>
    <condition>Platelet Disorder</condition>
    <condition>Thrombocytopathy</condition>
    <arm_group>
      <arm_group_label>Suspected</arm_group_label>
      <description>Suspected Platelet Function Disorder during bleeding investigation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Confirmed</arm_group_label>
      <description>Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients recruited at Karolinska University Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria, known defects:&#xD;
  &#xD;
            -  Known platelet function disorder under follow-up at Karolinska University Hospital&#xD;
               (genetic or functional assay)&#xD;
  &#xD;
            -  High likelihood of platelet function disorder (aberrant screening test with&#xD;
               inheritance)&#xD;
  &#xD;
            -  Family investigation for platelet disorder&#xD;
  &#xD;
          Exclusion Criteria, known defects::&#xD;
  &#xD;
            -  Antiplatelet or anticoagulant drugs&#xD;
  &#xD;
            -  vWF:GPIb below 0.40 IU/mL&#xD;
  &#xD;
            -  Hematocrit below 0.35 or above 0.50&#xD;
  &#xD;
            -  Other coagulation disorder&#xD;
  &#xD;
          Inclusion Criteria, suspected platelet function disorder:&#xD;
  &#xD;
            -  Bleeding investigation at Karolinska University Hospital&#xD;
  &#xD;
          Exclusion Criteria, suspected platelet function disorder::&#xD;
  &#xD;
            -  Antiplatelet or anticoagulant drugs&#xD;
  &#xD;
            -  vWF:GPIb below 0.40 IU/mL&#xD;
  &#xD;
            -  Hematocrit below 0.35 or above 0.50&#xD;
  &#xD;
            -  Other coagulation disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Karolinska University Hospital</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diagnostic accuracy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Blood Platelet Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT05985668
  org study id: K-2023-0991
  nct id: NCT05985668
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to improve platelet function testing during bleeding investigations. To this
        end, the study will evaluate the diagnostic accuracy of novel platelet function tests in
        patients with confirmed or suspected platelet function disorders. Study participants will be
        recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska
        University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Platelet-thrombus formation on collagen surface
  time frame: At study inclusion
  description: Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited.
  measure: Platelet count effect on platelet-thrombus formation on collagen surface
  time frame: At study inclusion
  description: Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count < 150 x 10^9 /L.
  measure: ddAVP effect on platelet-thrombus formation on collagen surface
  time frame: Immediately before and 1 hour after administration of ddAVP.
  description: Whole-blood platelet-thrombus formation on collagen surface, similar as for primary outcome measurement. In a subset of patients with a clinical indication (physician discretion).
  measure: Thrombus formation on collagen/TF
  time frame: At study inclusion
  description: Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor.
  arm group label: Suspected
  description: Suspected Platelet Function Disorder during bleeding investigation
  arm group label: Confirmed
  description: Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Blood Platelet Disorders
  sharing ipd: Yes