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/NCT05996679</url>
    </required_header>
    <id_info>
      <org_study_id>5761</org_study_id>
      <nct_id>NCT05996679</nct_id>
    </id_info>
    <brief_title>Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study</brief_title>
    <acronym>ASARD-TMA</acronym>
    <official_title>Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Recently a pilot study was conducted to evaluate the impact of an electronic alert (e-alert)&#xD;
        triggered by the automated algorithm in the efficiency and rapidity in TMA patients'&#xD;
        identification in our University Hospital A. Gemelli over 12 months.the TMA diagnostic&#xD;
        algorithm has been implemented in the laboratory software of the hospital and applied&#xD;
        whenever a patient in the Emergency ward or any other department undergoes blood tests that&#xD;
        include platelet count and lactate dehydrogenase. The basic profile in the Emergency ward&#xD;
        always has these two parameters. The algorithm automatically identifies patients with a&#xD;
        predicted probability of TMA &gt;90% (6); if this criterion is associated with a platelet&#xD;
        count&lt;100 x 109/L, an automated warning to the hematologist on-call is issued with an SMS,&#xD;
        and the patient enters the TMA diagnostic process defined in the diagnostic and treatment&#xD;
        pathways (Percorso Diagnostico e Terapeutico Assistensiale, PDTA). The on-duty hematologist&#xD;
        urgently evaluates the patient for whom a warning has been issued, relating with the&#xD;
        clinician(s) of the ward in which the patient is located. If the suspicion of TMA is&#xD;
        confirmed, the diagnostic procedures outlined in the PDTA are performed, with the immediate&#xD;
        execution of 2nd level tests. If the on-duty hematologist considers the diagnosis of aHUS&#xD;
        possible, they contact the on-call Nephrologist directly for immediate diagnostic&#xD;
        investigation and specific urgent therapeutic measures, as needed. The TMA-expert&#xD;
        Hematologist and/or TMA-expert Nephrologist is notified as soon as possible by the on-duty&#xD;
        hematologist of all cases, both highly suspected and uncertain, and follow up all patients to&#xD;
        complete the diagnostic workup to confirm or rule out the diagnosis and implement the&#xD;
        appropriate clinical measures.&#xD;
  &#xD;
        Therefore, the treatment in smaller hospitals that do not have a 24-hour hematological guard&#xD;
        service available and the same awareness for TMA.&#xD;
  &#xD;
        The present study aims to validate these results by testing the system in a multicenter study&#xD;
        involving centers with different availability of the hematologist and awareness for TMA.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Time of diagnosis and treatment of Thrombotic microangiopathies</measure>
      <time_frame>24 months</time_frame>
      <description>Evaluating algorithm to speed up diagnosis and treatment of TMA in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA.</description>
    </primary_outcome>
    <enrollment type="Anticipated">29</enrollment>
    <condition>Thrombotic Microangiopathies</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study will be conducted in 4 Hospitals (Nefrologia e Dialisi Ospedale Maggiore Verona;&#xD;
          Area Aggregata di Ematologia, Fondazione Policlinico Tor Vergata, Roma; Nefrologia e&#xD;
          Dialisi ASST Santi Paolo e Carlo, Università di Milano; Nefrologia e Dialisi AOU G. Martino&#xD;
          - Università degli Studi di Messina) over 12 months.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients admitted to the Emergency ward or inpatients of the involved Hospitals with&#xD;
          suspicion of TMA:&#xD;
  &#xD;
            -  Based on the clinical evaluation of the care physicians&#xD;
  &#xD;
            -  Based on the alerts issued by the automated algorithm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a predictive probability of TMA &lt; 90% (6) according to the diagnostic&#xD;
               algorithm&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>DE STEFANO VALERIO</investigator_full_name>
      <investigator_title>Full Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vascular Diseases</mesh_term>
      <mesh_term>Thrombotic Microangiopathies</mesh_term>
    </condition_browse>
    <!-- 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/NCT05996679
  org study id: 5761
  nct id: NCT05996679
  lead sponsor: 
  has dmc: No
  Recently a pilot study was conducted to evaluate the impact of an electronic alert (e-alert)
        triggered by the automated algorithm in the efficiency and rapidity in TMA patients'
        identification in our University Hospital A. Gemelli over 12 months.the TMA diagnostic
        algorithm has been implemented in the laboratory software of the hospital and applied
        whenever a patient in the Emergency ward or any other department undergoes blood tests that
        include platelet count and lactate dehydrogenase. The basic profile in the Emergency ward
        always has these two parameters. The algorithm automatically identifies patients with a
        predicted probability of TMA >90% (6); if this criterion is associated with a platelet
        count<100 x 109/L, an automated warning to the hematologist on-call is issued with an SMS,
        and the patient enters the TMA diagnostic process defined in the diagnostic and treatment
        pathways (Percorso Diagnostico e Terapeutico Assistensiale, PDTA). The on-duty hematologist
        urgently evaluates the patient for whom a warning has been issued, relating with the
        clinician(s) of the ward in which the patient is located. If the suspicion of TMA is
        confirmed, the diagnostic procedures outlined in the PDTA are performed, with the immediate
        execution of 2nd level tests. If the on-duty hematologist considers the diagnosis of aHUS
        possible, they contact the on-call Nephrologist directly for immediate diagnostic
        investigation and specific urgent therapeutic measures, as needed. The TMA-expert
        Hematologist and/or TMA-expert Nephrologist is notified as soon as possible by the on-duty
        hematologist of all cases, both highly suspected and uncertain, and follow up all patients to
        complete the diagnostic workup to confirm or rule out the diagnosis and implement the
        appropriate clinical measures.
  
        Therefore, the treatment in smaller hospitals that do not have a 24-hour hematological guard
        service available and the same awareness for TMA.
  
        The present study aims to validate these results by testing the system in a multicenter study
        involving centers with different availability of the hematologist and awareness for TMA.
  observational model: Other
  time perspective: Prospective
  measure: Time of diagnosis and treatment of Thrombotic microangiopathies
  time frame: 24 months
  description: Evaluating algorithm to speed up diagnosis and treatment of TMA in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: DE STEFANO VALERIO
  investigator title: Full Professor
  mesh term: Vascular Diseases
  mesh term: Thrombotic Microangiopathies