<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/NCT02976610</url>
  </required_header>
  <id_info>
    <org_study_id>HC001</org_study_id>
    <nct_id>NCT02976610</nct_id>
  </id_info>
  <brief_title>Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.</brief_title>
  <official_title>Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hemcheck Sweden AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Landstinget i Värmland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hemcheck Sweden AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of&#xD;
      care test is introduced in an emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a blood sample process, the preanalytical phase is accountable for a vast majority of&#xD;
      laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of&#xD;
      sample rejection. Recollection of blood from the patient causes extra suffering, increased&#xD;
      turn-around-time hence delayed treatment, and unnecessary extra costs for the health care&#xD;
      system.&#xD;
&#xD;
      Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single&#xD;
      use test is attached to the blood sample in direct conjunction to the sampling process.&#xD;
&#xD;
      Patients will be selected by consecutive selection at the emergency department if blood tests&#xD;
      ordered by the physician meet the inclusion criteria. Patients will be randomized into one of&#xD;
      two groups. All health care professionals participating in this study has attended in a&#xD;
      standard education program in operating H-POCT.&#xD;
&#xD;
      If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood&#xD;
      sample according to routine.&#xD;
&#xD;
      If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform&#xD;
      blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or&#xD;
      all of the analyzes: Liver status, Electrolytes and Troponin T.)&#xD;
&#xD;
      If the hemolysis point of care test (H-poct) indicate a positive test result the Lithium&#xD;
      Heparin vacuum tube and the attached H-poct will be discarded and a new sample will be&#xD;
      collected and screened for hemolysis until the user receives a negative sample that is not&#xD;
      hemolyzed.&#xD;
&#xD;
      This study takes place in a county hospital with 430 beds and the emergency department treats&#xD;
      59000 patients yearly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">May 5, 2017</completion_date>
  <primary_completion_date type="Actual">May 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemolysis frequency.</measure>
    <time_frame>Through 52 weeks</time_frame>
    <description>Compare the volume of hemolyzed blood samples in two groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1671</enrollment>
  <condition>Hemolysis</condition>
  <condition>Blood Specimen Collection</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the blood sampling the health care professional will screen all vacuum Lithium Heparin tubes, with the Hemolysis point-of-care test (H-POCT). If the health care professional receives a negative test the bloodsample is sent to the local laboratory.&#xD;
If H-POCT indicates a positive test, of free hemoglobin in plasma, the bloodsample and H-POCT will be discarded and a new sample will be collected and screened for hemolysis. This can be repeated 3 times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemolysis Point-of-Care test</intervention_name>
    <description>Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Blood sample analysis ordered:&#xD;
&#xD;
          -  Electrolyte&#xD;
&#xD;
          -  Troponin T&#xD;
&#xD;
          -  ALAT, ASAT, ALP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incompletely filled tubes&#xD;
&#xD;
          -  Minors (&lt; 18 years)&#xD;
&#xD;
          -  Patient not fit according to the health care professional assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars O Hansson, MD-PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Landstinget i Värmland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anders Hallberg, MD-PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency department, Central Hospital Karlstad</name>
      <address>
        <city>Karlstad</city>
        <state>Värmland</state>
        <zip>65230</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>June 9, 2017</last_update_submitted>
  <last_update_submitted_qc>June 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Landstinget i Värmland</investigator_affiliation>
    <investigator_full_name>Lars-Olof Hansson</investigator_full_name>
    <investigator_title>Clinical chemist, physician.</investigator_title>
  </responsible_party>
  <keyword>hemolysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Hemolysis</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/NCT02976610
org study id: HC001
nct id: NCT02976610
lead sponsor: 
collaborator: 
has dmc: No
This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of
      care test is introduced in an emergency department.
In a blood sample process, the preanalytical phase is accountable for a vast majority of
      laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of
      sample rejection. Recollection of blood from the patient causes extra suffering, increased
      turn-around-time hence delayed treatment, and unnecessary extra costs for the health care
      system.

      Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single
      use test is attached to the blood sample in direct conjunction to the sampling process.

      Patients will be selected by consecutive selection at the emergency department if blood tests
      ordered by the physician meet the inclusion criteria. Patients will be randomized into one of
      two groups. All health care professionals participating in this study has attended in a
      standard education program in operating H-POCT.

      If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood
      sample according to routine.

      If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform
      blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or
      all of the analyzes: Liver status, Electrolytes and Troponin T.)

      If the hemolysis point of care test (H-poct) indicate a positive test result the Lithium
      Heparin vacuum tube and the attached H-poct will be discarded and a new sample will be
      collected and screened for hemolysis until the user receives a negative sample that is not
      hemolyzed.

      This study takes place in a county hospital with 430 beds and the emergency department treats
      59000 patients yearly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Hemolysis frequency.
time frame: Through 52 weeks
description: Compare the volume of hemolyzed blood samples in two groups.
arm group label: 1
arm group type: No Intervention
description: This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department.
arm group label: 2
arm group type: Experimental
description: During the blood sampling the health care professional will screen all vacuum Lithium Heparin tubes, with the Hemolysis point-of-care test (H-POCT). If the health care professional receives a negative test the bloodsample is sent to the local laboratory.
If H-POCT indicates a positive test, of free hemoglobin in plasma, the bloodsample and H-POCT will be discarded and a new sample will be collected and screened for hemolysis. This can be repeated 3 times.
intervention type: Device
intervention name: Hemolysis Point-of-Care test
description: Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma
arm group label: 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lars O Hansson, MD-PhD
role: Study Chair
affiliation: Landstinget i Värmland
last name: Anders Hallberg, MD-PhD
role: Study Chair
affiliation: Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Landstinget i Värmland
investigator full name: Lars-Olof Hansson
investigator title: Clinical chemist, physician.
mesh term: Emergencies
mesh term: Hemolysis
sharing ipd: No