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/NCT06028906</url>
    </required_header>
    <id_info>
      <org_study_id>OptCPP, ver B</org_study_id>
      <secondary_id>MIP-20-216</secondary_id>
      <nct_id>NCT06028906</nct_id>
    </id_info>
    <brief_title>Research of Optimal Cerebral Perfusion Pressure Diagnosis</brief_title>
    <acronym>optCPP</acronym>
    <official_title>Research and Development of Innovative Method and Technology for Cerebral Perfusion Pressure Diagnosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vilnius University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kaunas University of Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vilnius University</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 research will investigate the hypothesis that timely identification of the optimal value&#xD;
        of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is&#xD;
        possible after detecting informative episodes of arterial blood pressure (ABP) that reflects&#xD;
        the physiological autoregulatory reactions of the cerebral blood flow,&#xD;
  &#xD;
        This biomedical study will be conducted to test this hypothesis and to develop an algorithm&#xD;
        for identification of optimal brain perfusion pressure within limited time (several tens of&#xD;
        minutes).&#xD;
  &#xD;
        The goal of this observational study is to test the method of timely optimal cerebral&#xD;
        perfusion pressure value or optimal arterial pressure value in intensive care patients after&#xD;
        brain surgery.&#xD;
  &#xD;
        The main question it aims to answer are: how long it takes to identify optimal cerebral&#xD;
        perfusion value when arterial blood pressure is changing within safe physiological limits.&#xD;
  &#xD;
        Objectives of the study&#xD;
  &#xD;
          1. To perform a prospective observational study by collecting multimodal physiological&#xD;
             brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP),&#xD;
             End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.&#xD;
  &#xD;
          2. To perform a retrospective analysis of the accumulated clinical monitoring data, in&#xD;
             order to create an algorithm for the identification of informative monitoring data&#xD;
             fragments, according to which it would be possible to identify the optimal cerebral&#xD;
             perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen&#xD;
             minutes).&#xD;
  &#xD;
          3. To perform a retrospective analysis of accumulated clinical monitoring data, determining&#xD;
             correlations of cerebral blood flow autoregulation and optCPP-related parameters with&#xD;
             the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral&#xD;
             ischemia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Optimal cerebral perfusion pressure (optCPP) management requires at least 4 hours of&#xD;
        patients' physiological data monitoring. Critical pathophysiological events in the injured&#xD;
        brain happen in minutes, not in hours.&#xD;
  &#xD;
        The research will investigate the hypothesis that timely identification of the optimal value&#xD;
        of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is&#xD;
        possible after detecting informative episodes of arterial blood pressure (ABP) that reflects&#xD;
        the physiological autoregulatory reactions of the cerebral blood flow,&#xD;
  &#xD;
        This biomedical study will be conducted to test this hypothesis and to develop an algorithm&#xD;
        for identification of optimal brain perfusion pressure within limited time (several tens of&#xD;
        minutes).&#xD;
  &#xD;
        The goal of this observational study is to test the method of timely optimal cerebral&#xD;
        perfusion pressure value or optimal arterial pressure value in intensive care patients after&#xD;
        brain surgery.&#xD;
  &#xD;
        The main question it aims to answer are: how long it takes to identify optimal cerebral&#xD;
        perfusion value when arterial blood pressure is changing within safe physiological limits.&#xD;
  &#xD;
        Objectives of the study&#xD;
  &#xD;
          1. To perform a prospective observational study by collecting multimodal physiological&#xD;
             brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP),&#xD;
             End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.&#xD;
  &#xD;
          2. To perform a retrospective analysis of the accumulated clinical monitoring data, in&#xD;
             order to create an algorithm for the identification of informative monitoring data&#xD;
             fragments, according to which it would be possible to identify the optimal cerebral&#xD;
             perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen&#xD;
             minutes).&#xD;
  &#xD;
          3. To perform a retrospective analysis of accumulated clinical monitoring data, determining&#xD;
             correlations of cerebral blood flow autoregulation and optCPP-related parameters with&#xD;
             the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral&#xD;
             ischemia.&#xD;
  &#xD;
        Timely identification of optCPP value and diagnosis of cerebrovascular autoregulation (CA)&#xD;
        will be performed according to the measured reaction of cerebral hemodynamics during the&#xD;
        detected ABP(t) changes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2021</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cerebral autoregulation index (pressure reactivity index PRx)</measure>
      <time_frame>PRx is measured when invasive intracranial pressure slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days).</time_frame>
      <description>Negative values of cerebral autoregulation index (PRx&lt;0) represent intact cerebral autoregulation, positive values (PRx&gt;0) show impaired cerebral autoregulation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cerebral autoregulation index (mean flow index Mx)</measure>
      <time_frame>Mx is measured when non-invasive cerebral blood flow slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days).</time_frame>
      <description>Negative values of cerebral autoregulation index (Mx&lt;0) represent intact cerebral autoregulation, positive values (Mx&gt;0) show impaired cerebral autoregulation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Optimal arterial blood pressure value</measure>
      <time_frame>Optimal arterial blood pressure value is identified when PRx or Mx data are available during multimodal clinical data collection in ICU (up to 7 days).</time_frame>
      <description>Optimal arterial blood pressure value is identified at the conditions of lowest values of cerebral autoregulation indexes by applying &quot;U-shape&quot; approximation on ABP and PRx (or Mx) data.&#xD;
  Identified optimal arterial blood pressure value is assumed as a targeted arterial blood pressure value for personalized cerebral perfusion management in the cases when U-shape approximation is determined.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patients' outcome</measure>
      <time_frame>GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission.</time_frame>
      <description>Patients' outcome is evaluated according to Glasgow Outcome Score (GOS). GOS scores are: 1 - death, 2 - persistent vegetative state, 3 - severe disability, 4 - moderate disability, 5 - low disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of cerebral ischemia and cerebral vasospasms</measure>
      <time_frame>CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary.</time_frame>
      <description>Occurrence of cerebral ischemia and cerebral vasospasms evaluated from Computed Tomography (CT) and Computed Tomography Angiography (CTA) scans</description>
    </secondary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Trauma, Brain</condition>
    <condition>Hemorrhage Cerebral</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Multimodal physiological monitoring and cerebral autoregulation monitoring</intervention_name>
      <description>Patients are monitored routinely during their treatment in ICU. Multimodal physiological monitoring include continuous monitoring of arterial blood pressure (ABP), intracranial pressure (ICP) (if available), ETCO2 (if available), cerebral perfusion pressure (if available), cerebral blood flow velocity (CBFV) and ECG.&#xD;
  Non-invasive cerebral autoregulation index Mx will by calculated as a Pearson correlation coefficient between slow ABP and slow CBFV waves.&#xD;
  Invasive cerebral autoregulation index (Pressure reactivity index PRx) will by calculated as a Pearson correlation coefficient between slow ABP and slow ICP waves.&#xD;
  Non invasive CBFV will be measured by using TCD device DWL Multi Dop-T. Invasive ICP will be measured by using Codman ICP Express or Raumedic ICP monitor.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will include patients treated at Vilnius University Hospital Santaros Klinikos&#xD;
          that undergo brain surgery after traumatic brain injury (TBI) or subarachnoid hemorrhage&#xD;
          (SAH).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Traumatic brain injury patients&#xD;
  &#xD;
            -  Subarachnoid hemorrhage patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  persons with mental disorders, but who can give consent to participate in biomedical&#xD;
               research;&#xD;
  &#xD;
            -  minors;&#xD;
  &#xD;
            -  students, if their participation in biomedical research is related to studies;&#xD;
  &#xD;
            -  persons living in care institutions;&#xD;
  &#xD;
            -  soldiers during their actual military service;&#xD;
  &#xD;
            -  employees of health care institutions where biomedical research is conducted,&#xD;
               subordinate to the researcher;&#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_official>
      <last_name>Saulius Rocka</last_name>
      <role>Principal Investigator</role>
      <affiliation>Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Saulius Rocka, Prof. Dr.</last_name>
      <phone>+37068743480</phone>
      <email>saulius.rocka@santa.lt</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vilnius University Hospital Santaros klinikos</name>
        <address>
          <city>Vilnius</city>
          <zip>08661</zip>
          <country>Lithuania</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Saulius Rocka, Prof. Dr.</last_name>
        <phone>+37068743480</phone>
        <email>saulius.rocka@santa.lt</email>
      </contact>
      <contact_backup>
        <last_name>Aidanas Preiksaitis, Dr</last_name>
        <phone>+37065915104</phone>
        <email>danas911@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Lithuania</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>optimal cerebral perfusion pressure</keyword>
    <keyword>optimal arterial pressure</keyword>
    <keyword>cerebral autoregulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Cerebral Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06028906
  org study id: OptCPP, ver B
  secondary id: MIP-20-216
  nct id: NCT06028906
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The research will investigate the hypothesis that timely identification of the optimal value
        of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is
        possible after detecting informative episodes of arterial blood pressure (ABP) that reflects
        the physiological autoregulatory reactions of the cerebral blood flow,
  
        This biomedical study will be conducted to test this hypothesis and to develop an algorithm
        for identification of optimal brain perfusion pressure within limited time (several tens of
        minutes).
  
        The goal of this observational study is to test the method of timely optimal cerebral
        perfusion pressure value or optimal arterial pressure value in intensive care patients after
        brain surgery.
  
        The main question it aims to answer are: how long it takes to identify optimal cerebral
        perfusion value when arterial blood pressure is changing within safe physiological limits.
  
        Objectives of the study
  
          1. To perform a prospective observational study by collecting multimodal physiological
             brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP),
             End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.
  
          2. To perform a retrospective analysis of the accumulated clinical monitoring data, in
             order to create an algorithm for the identification of informative monitoring data
             fragments, according to which it would be possible to identify the optimal cerebral
             perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen
             minutes).
  
          3. To perform a retrospective analysis of accumulated clinical monitoring data, determining
             correlations of cerebral blood flow autoregulation and optCPP-related parameters with
             the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral
             ischemia.
  Optimal cerebral perfusion pressure (optCPP) management requires at least 4 hours of
        patients' physiological data monitoring. Critical pathophysiological events in the injured
        brain happen in minutes, not in hours.
  
        The research will investigate the hypothesis that timely identification of the optimal value
        of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is
        possible after detecting informative episodes of arterial blood pressure (ABP) that reflects
        the physiological autoregulatory reactions of the cerebral blood flow,
  
        This biomedical study will be conducted to test this hypothesis and to develop an algorithm
        for identification of optimal brain perfusion pressure within limited time (several tens of
        minutes).
  
        The goal of this observational study is to test the method of timely optimal cerebral
        perfusion pressure value or optimal arterial pressure value in intensive care patients after
        brain surgery.
  
        The main question it aims to answer are: how long it takes to identify optimal cerebral
        perfusion value when arterial blood pressure is changing within safe physiological limits.
  
        Objectives of the study
  
          1. To perform a prospective observational study by collecting multimodal physiological
             brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP),
             End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.
  
          2. To perform a retrospective analysis of the accumulated clinical monitoring data, in
             order to create an algorithm for the identification of informative monitoring data
             fragments, according to which it would be possible to identify the optimal cerebral
             perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen
             minutes).
  
          3. To perform a retrospective analysis of accumulated clinical monitoring data, determining
             correlations of cerebral blood flow autoregulation and optCPP-related parameters with
             the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral
             ischemia.
  
        Timely identification of optCPP value and diagnosis of cerebrovascular autoregulation (CA)
        will be performed according to the measured reaction of cerebral hemodynamics during the
        detected ABP(t) changes.
  observational model: Cohort
  time perspective: Prospective
  measure: Cerebral autoregulation index (pressure reactivity index PRx)
  time frame: PRx is measured when invasive intracranial pressure slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days).
  description: Negative values of cerebral autoregulation index (PRx<0) represent intact cerebral autoregulation, positive values (PRx>0) show impaired cerebral autoregulation.
  measure: Cerebral autoregulation index (mean flow index Mx)
  time frame: Mx is measured when non-invasive cerebral blood flow slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days).
  description: Negative values of cerebral autoregulation index (Mx<0) represent intact cerebral autoregulation, positive values (Mx>0) show impaired cerebral autoregulation.
  measure: Optimal arterial blood pressure value
  time frame: Optimal arterial blood pressure value is identified when PRx or Mx data are available during multimodal clinical data collection in ICU (up to 7 days).
  description: Optimal arterial blood pressure value is identified at the conditions of lowest values of cerebral autoregulation indexes by applying "U-shape" approximation on ABP and PRx (or Mx) data.
  Identified optimal arterial blood pressure value is assumed as a targeted arterial blood pressure value for personalized cerebral perfusion management in the cases when U-shape approximation is determined.
  measure: Patients' outcome
  time frame: GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission.
  description: Patients' outcome is evaluated according to Glasgow Outcome Score (GOS). GOS scores are: 1 - death, 2 - persistent vegetative state, 3 - severe disability, 4 - moderate disability, 5 - low disability.
  measure: Occurrence of cerebral ischemia and cerebral vasospasms
  time frame: CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary.
  description: Occurrence of cerebral ischemia and cerebral vasospasms evaluated from Computed Tomography (CT) and Computed Tomography Angiography (CTA) scans
  intervention type: Diagnostic Test
  intervention name: Multimodal physiological monitoring and cerebral autoregulation monitoring
  description: Patients are monitored routinely during their treatment in ICU. Multimodal physiological monitoring include continuous monitoring of arterial blood pressure (ABP), intracranial pressure (ICP) (if available), ETCO2 (if available), cerebral perfusion pressure (if available), cerebral blood flow velocity (CBFV) and ECG.
  Non-invasive cerebral autoregulation index Mx will by calculated as a Pearson correlation coefficient between slow ABP and slow CBFV waves.
  Invasive cerebral autoregulation index (Pressure reactivity index PRx) will by calculated as a Pearson correlation coefficient between slow ABP and slow ICP waves.
  Non invasive CBFV will be measured by using TCD device DWL Multi Dop-T. Invasive ICP will be measured by using Codman ICP Express or Raumedic ICP monitor.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Saulius Rocka
  role: Principal Investigator
  affiliation: Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos
  last name: Saulius Rocka, Prof. Dr.
  phone: +37068743480
  email: saulius.rocka@santa.lt
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Lithuania
  responsible party type: Sponsor
  mesh term: Brain Injuries, Traumatic
  mesh term: Cerebral Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: No