<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/NCT04442659</url>
  </required_header>
  <id_info>
    <org_study_id>G18.058</org_study_id>
    <nct_id>NCT04442659</nct_id>
  </id_info>
  <brief_title>Prehospital Prediction of Large Anterior Vessel Occlusion</brief_title>
  <acronym>PHPLAVO</acronym>
  <official_title>Prediction of Large Anterior Vessel Occlusion: a Prospective Observational Study Comparing Prehospital Prediction Scales</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alrijne Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Center Haaglanden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haga Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groene Hart Ziekenhuis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Reinier de Graaf Groep</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Leiden University Medical Center</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>
      For the clinical benefit of intravenous thrombolysis &quot;IVT&quot; or intra-arterial thrombectomy&#xD;
      &quot;IAT&quot; time is the most crucial factor. Reducing the time between stroke onset en treatment is&#xD;
      therefore a major goal. Since IAT is only suitable for stroke due to large anterior vessel&#xD;
      occlusion &quot;LAVO&quot; which is only performed in specialized comprehensive stroke centers &quot;CSC&quot;,&#xD;
      triage of LAVO-patients in the prehospital phase (i.e. in the ambulance) in order to directly&#xD;
      allocate them to such a specialized CSC will save vital time (time=brain!). Several&#xD;
      LAVO-prediction scales for clinical triage have been developed but most were tested in-&#xD;
      hospital by experienced neurologists. Consequently, there is a great need for validation of&#xD;
      these scales in the prehospital setting by Emergency Medical Services &quot;EMS&quot; personnel.&#xD;
&#xD;
      Objective: to recalibrate, validate performance and assess feasibility of several existing&#xD;
      LAVO-prediction scales in the prehospital phase (i.e. assessment by EMS personnel).&#xD;
&#xD;
      Study design: multiregional, multicenter observational cohort study to investigate&#xD;
      performance and feasibility of LAVO-prediction scales a.&#xD;
&#xD;
      Study population: all patients potentially eligible for IVTIAT according to the protocol used&#xD;
      by EMS personnel except for when younger than 18 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in two EMS regions: Hollands Midden and Haaglanden. In addition,&#xD;
      all hospitals in these regions that treat over 30 patients per year with IVT will&#xD;
      participate, including at least 1 CSC with IAT-availability per region. These hospitals are:&#xD;
      Leiden University Medical Center &quot;LUMC&quot;; Alrijne hospital (location Leiderdorp); Haaglanden&#xD;
      Medical Center (HMC+); Haga hospital; LangeLand hospital (LLZ) and Reinier de Graaf hospital&#xD;
      (RdGG).&#xD;
&#xD;
      The observational design is pragmatic and reflects standard practice for acute stroke care.&#xD;
&#xD;
      inclusion: All patients with suspected stroke potentially eligible for IVT/IAT as estimated&#xD;
      by the on-site EMS nurse.&#xD;
&#xD;
      A web based application is used that merely structures observations that are currently noted&#xD;
      on transport charts. EMS personnel will have access to the web-based application via the&#xD;
      iPad/tablet/smartphone/computer on which the EMS transport chart is already filled out as&#xD;
      part of standard care. Or via their patient record as used in the ambulance.&#xD;
&#xD;
      The application will consist of the following items:&#xD;
&#xD;
        -  EMS transport number&#xD;
&#xD;
        -  time of symptom onset&#xD;
&#xD;
        -  probability of LAVO estimated by EMS nurse&#xD;
&#xD;
        -  9-12 questions to structure clinical observations made by the EMS nurse.&#xD;
&#xD;
      The application will be straightforward and designed in close co-operation with EMS&#xD;
      personnel. With the items acquired all prediction scales can be reconstructed.&#xD;
&#xD;
      Data of the application will be retrieved retrospectively and coupled with retrospectively&#xD;
      collected data from the participating hospitals by a trusted third party&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>symptomatic Large Anterior Vessel Occlusion</measure>
    <time_frame>on admission</time_frame>
    <description>TICI score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility outcome</measure>
    <time_frame>&quot;within first hour&quot;</time_frame>
    <description>reconstruction rate of cuttoff and/or full scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>final diagnosis</measure>
    <time_frame>&quot;Three months&quot;</time_frame>
    <description>diagnosis after discharge and/or after three months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endovascular therpay</measure>
    <time_frame>&quot;within first 24 hours of admission&quot;</time_frame>
    <description>EVT</description>
  </secondary_outcome>
  <enrollment type="Actual">2000</enrollment>
  <condition>Stroke, Acute</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>pre hospital triage tool</intervention_name>
    <description>EMS workers fill in an application containing 10-13 vclinical items</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All stroke codes within the ambulance regions of the Emergency medical services Hollands&#xD;
        midden or Haaglanden.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute stroke code activated by EMS personnel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#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>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <state>Zuid Holland</state>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://stroketriage.com/collect/start/16</url>
    <description>Stroke triage app</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>NyikaKruyt</investigator_full_name>
    <investigator_title>Md, PhD</investigator_title>
  </responsible_party>
  <keyword>large vessel occlusion</keyword>
  <keyword>Endovascular trombectomy</keyword>
  <keyword>pre-hospital stroke triage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT04442659
org study id: G18.058
nct id: NCT04442659
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For the clinical benefit of intravenous thrombolysis "IVT" or intra-arterial thrombectomy
      "IAT" time is the most crucial factor. Reducing the time between stroke onset en treatment is
      therefore a major goal. Since IAT is only suitable for stroke due to large anterior vessel
      occlusion "LAVO" which is only performed in specialized comprehensive stroke centers "CSC",
      triage of LAVO-patients in the prehospital phase (i.e. in the ambulance) in order to directly
      allocate them to such a specialized CSC will save vital time (time=brain!). Several
      LAVO-prediction scales for clinical triage have been developed but most were tested in-
      hospital by experienced neurologists. Consequently, there is a great need for validation of
      these scales in the prehospital setting by Emergency Medical Services "EMS" personnel.

      Objective: to recalibrate, validate performance and assess feasibility of several existing
      LAVO-prediction scales in the prehospital phase (i.e. assessment by EMS personnel).

      Study design: multiregional, multicenter observational cohort study to investigate
      performance and feasibility of LAVO-prediction scales a.

      Study population: all patients potentially eligible for IVTIAT according to the protocol used
      by EMS personnel except for when younger than 18 years.
The study will be conducted in two EMS regions: Hollands Midden and Haaglanden. In addition,
      all hospitals in these regions that treat over 30 patients per year with IVT will
      participate, including at least 1 CSC with IAT-availability per region. These hospitals are:
      Leiden University Medical Center "LUMC"; Alrijne hospital (location Leiderdorp); Haaglanden
      Medical Center (HMC+); Haga hospital; LangeLand hospital (LLZ) and Reinier de Graaf hospital
      (RdGG).

      The observational design is pragmatic and reflects standard practice for acute stroke care.

      inclusion: All patients with suspected stroke potentially eligible for IVT/IAT as estimated
      by the on-site EMS nurse.

      A web based application is used that merely structures observations that are currently noted
      on transport charts. EMS personnel will have access to the web-based application via the
      iPad/tablet/smartphone/computer on which the EMS transport chart is already filled out as
      part of standard care. Or via their patient record as used in the ambulance.

      The application will consist of the following items:

        -  EMS transport number

        -  time of symptom onset

        -  probability of LAVO estimated by EMS nurse

        -  9-12 questions to structure clinical observations made by the EMS nurse.

      The application will be straightforward and designed in close co-operation with EMS
      personnel. With the items acquired all prediction scales can be reconstructed.

      Data of the application will be retrieved retrospectively and coupled with retrospectively
      collected data from the participating hospitals by a trusted third party
observational model: Cohort
time perspective: Prospective
measure: symptomatic Large Anterior Vessel Occlusion
time frame: on admission
description: TICI score
measure: Feasibility outcome
time frame: "within first hour"
description: reconstruction rate of cuttoff and/or full scale
measure: final diagnosis
time frame: "Three months"
description: diagnosis after discharge and/or after three months.
measure: Endovascular therpay
time frame: "within first 24 hours of admission"
description: EVT
intervention type: Diagnostic Test
intervention name: pre hospital triage tool
description: EMS workers fill in an application containing 10-13 vclinical items
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
url: https://stroketriage.com/collect/start/16
description: Stroke triage app
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: NyikaKruyt
investigator title: Md, PhD
mesh term: Stroke
sharing ipd: Undecided