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/NCT05963685</url>
    </required_header>
    <id_info>
      <org_study_id>MT-ALARM</org_study_id>
      <nct_id>NCT05963685</nct_id>
    </id_info>
    <brief_title>Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy</brief_title>
    <official_title>Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Munich Municipal Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Munich Municipal Hospital</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>
        The aim of this study is to evaluate the impact of a standardized alarming system on&#xD;
        treatment times and workflow in stroke patients with interhospital transfer for mechanical&#xD;
        thrombectomy (MT). The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is the implementation of a standardized alarming system associated with shorter transfer&#xD;
             and treatment times?&#xD;
  &#xD;
          -  Is the implementation of a standardized alarming system associated with a better&#xD;
             adherence on existing standard operating procedures for interhospital transfer? We will&#xD;
             analyze data from our existing thrombectomy registry comparing time periods before and&#xD;
             after introduction of the MT alarming system.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 16, 2022</start_date>
    <completion_date type="Anticipated">March 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</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>decision-to-groin time</measure>
      <time_frame>24 hours</time_frame>
      <description>time from decision for MT (while patient still in the primary stroke center) to groin puncture (start of mechanical thrombectomy procedure in the primary thrombectomy center)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>decision-to-departure time</measure>
      <time_frame>24 hours</time_frame>
      <description>time from decision for MT to departure of the patient from primary stroke center (to the primary thrombectomy center)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decision-to-arrival time</measure>
      <time_frame>24 hours</time_frame>
      <description>time from decision for MT to arrival of the patient at the primary thrombectomy center</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>arrival-to-groin time</measure>
      <time_frame>24 hours</time_frame>
      <description>time from arrival of the patient at the primary thrombectomy center to groin puncture (start of mechanical thrombectomy procedure)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rate of refusal of transfer requests due to lack of capacity</measure>
      <time_frame>24 hours</time_frame>
      <description>rate of patients that had to be transferred to a secondary thrombectomy center instead of the primary thrombectomy centre due to lack of capacity in the referral clinic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decision-to-transfer request time</measure>
      <time_frame>24 hours</time_frame>
      <description>Time from decision for MT to request of emergency medical service for interhospital transfer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Periprocedural complications</measure>
      <time_frame>24 hours</time_frame>
      <description>rate of periprocedural complications during MT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Successful outcome of MT (mTICI &gt; 2b)</measure>
      <time_frame>24 hours</time_frame>
      <description>rate of successfully performed MT (mTICI &gt; 2b) of all patients with attempted MT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>groin-to-recanalization time</measure>
      <time_frame>24 hours</time_frame>
      <description>Time from groin puncture to successful recanalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events within 7 days</measure>
      <time_frame>7 days</time_frame>
      <description>Adverse events within the first 7 days after transfer to referral center</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">280</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>pre implementation period</arm_group_label>
      <description>stroke patients transferred within the 6 months before introduction of the alarming system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>implementation period</arm_group_label>
      <description>stroke patients transferred within the 6 months after introduction of the alarming system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>post implementation period</arm_group_label>
      <description>stroke patients transferred within the 6-12 months after introduction of the alarming system</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standardized MT alarming system</intervention_name>
      <description>Standardized alarming system via telephone loop in the primary thrombectomy centre triggered immediately after decision to mechanical thrombectomy in stroke patients admitted in primary stroke centers</description>
      <arm_group_label>implementation period</arm_group_label>
      <arm_group_label>post implementation period</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Acute ischemic stroke patients admitted to one of 7 nonurban primary stroke centers with&#xD;
          subsequent interhospital transfer to a referral center for mechanical thrombectomy in&#xD;
          Southeast Bavaria, Germany.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt;= 18 years&#xD;
  &#xD;
            -  diagnosis of acute ischemic stroke&#xD;
  &#xD;
            -  indication for mechanical thrombectomy&#xD;
  &#xD;
            -  admission to one of 7 participating primary stroke centers within in the catchment&#xD;
               area of the referral center&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unclear indication for mechanical thrombectomy (patients admitted for perfusion&#xD;
               imaging before decision for or against a MT)&#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_contact>
      <last_name>Hanni Wiestler, MD</last_name>
      <phone>+49 89 6210 5895</phone>
      <email>hanni.wiestler@muenchen-klinik.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nikolai Hubert</last_name>
      <phone>+49 89 6210 3325</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Munich Municipal Hospital</name>
        <address>
          <city>Munich</city>
          <state>Bavaria</state>
          <zip>81545</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nikolai Hubert, MSc</last_name>
        <phone>+49 89 6210 3325</phone>
        <email>nikolai.hubert@muenchen-klinik.de</email>
      </contact>
      <contact_backup>
        <last_name>Hanni Wiestler, MD</last_name>
        <phone>+49 89 6210 5895</phone>
        <email>hanni.wiestler@muenchen-klinik.de</email>
      </contact_backup>
      <investigator>
        <last_name>Hanni Wiestler, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nikolai Hubert, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mechanical thrombectomy, telestroke, drip and ship, interhospital transfer, communication</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No plan to make IPD available to other researchers.</ipd_description>
    </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/NCT05963685
  org study id: MT-ALARM
  nct id: NCT05963685
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the impact of a standardized alarming system on
        treatment times and workflow in stroke patients with interhospital transfer for mechanical
        thrombectomy (MT). The main questions it aims to answer are:
  
          -  Is the implementation of a standardized alarming system associated with shorter transfer
             and treatment times?
  
          -  Is the implementation of a standardized alarming system associated with a better
             adherence on existing standard operating procedures for interhospital transfer? We will
             analyze data from our existing thrombectomy registry comparing time periods before and
             after introduction of the MT alarming system.
  observational model: Cohort
  time perspective: Prospective
  measure: decision-to-groin time
  time frame: 24 hours
  description: time from decision for MT (while patient still in the primary stroke center) to groin puncture (start of mechanical thrombectomy procedure in the primary thrombectomy center)
  measure: decision-to-departure time
  time frame: 24 hours
  description: time from decision for MT to departure of the patient from primary stroke center (to the primary thrombectomy center)
  measure: decision-to-arrival time
  time frame: 24 hours
  description: time from decision for MT to arrival of the patient at the primary thrombectomy center
  measure: arrival-to-groin time
  time frame: 24 hours
  description: time from arrival of the patient at the primary thrombectomy center to groin puncture (start of mechanical thrombectomy procedure)
  measure: rate of refusal of transfer requests due to lack of capacity
  time frame: 24 hours
  description: rate of patients that had to be transferred to a secondary thrombectomy center instead of the primary thrombectomy centre due to lack of capacity in the referral clinic
  measure: decision-to-transfer request time
  time frame: 24 hours
  description: Time from decision for MT to request of emergency medical service for interhospital transfer
  measure: Periprocedural complications
  time frame: 24 hours
  description: rate of periprocedural complications during MT
  measure: Successful outcome of MT (mTICI > 2b)
  time frame: 24 hours
  description: rate of successfully performed MT (mTICI > 2b) of all patients with attempted MT
  measure: groin-to-recanalization time
  time frame: 24 hours
  description: Time from groin puncture to successful recanalization
  measure: Adverse events within 7 days
  time frame: 7 days
  description: Adverse events within the first 7 days after transfer to referral center
  arm group label: pre implementation period
  description: stroke patients transferred within the 6 months before introduction of the alarming system
  arm group label: implementation period
  description: stroke patients transferred within the 6 months after introduction of the alarming system
  arm group label: post implementation period
  description: stroke patients transferred within the 6-12 months after introduction of the alarming system
  intervention type: Other
  intervention name: standardized MT alarming system
  description: Standardized alarming system via telephone loop in the primary thrombectomy centre triggered immediately after decision to mechanical thrombectomy in stroke patients admitted in primary stroke centers
  arm group label: implementation period
  arm group label: post implementation period
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hanni Wiestler, MD
  phone: +49 89 6210 5895
  email: hanni.wiestler@muenchen-klinik.de
  last name: Nikolai Hubert
  phone: +49 89 6210 3325
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  sharing ipd: No
  ipd description: No plan to make IPD available to other researchers.