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/NCT06006975</url>
    </required_header>
    <id_info>
      <org_study_id>EWoDCI ver.C</org_study_id>
      <secondary_id>01.2.2-LMT-K-718-03-0091</secondary_id>
      <nct_id>NCT06006975</nct_id>
    </id_info>
    <brief_title>Early Warning of Delayed Cerebral Ischemia</brief_title>
    <acronym>EWoDCI</acronym>
    <official_title>R&amp;D of Innovative Technology for Predicting and Early Warning of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage</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>
      <collaborator>
        <agency>Lithuanian University of Health Sciences</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 goal of this observational study is to learn about the possibility to predict clinical&#xD;
        course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of&#xD;
        clinical data available in early pre-vasospasm phase.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography&#xD;
             Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be&#xD;
             used to predict development of cerebral vasospasms, delayed cerebral ischemia and&#xD;
             patients' outcome.&#xD;
  &#xD;
          -  What biomarkers retrieved from transcranial Doppler examinations in early pre vasospasm&#xD;
             can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and&#xD;
             patients' outcome.&#xD;
  &#xD;
          -  What biomarkers retrieved from multimodal physiological monitoring in early pre&#xD;
             vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral&#xD;
             ischemia and patients' outcome.&#xD;
  &#xD;
          -  What is impact of other clinical data (blood test results, age, gender, etc.) on&#xD;
             development of cerebral vasospasms and delayed cerebral ischemia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        An adequate timely prognosis of cerebral vasospasms and delayed cerebral ischemia (DCI)&#xD;
        occuring after spontaneous aneurysmal subarachnoid haemorrhage (aSAH), is vitally essential&#xD;
        to selecting an individualized and timely treatment strategy. Cerebral vasospasms (CV) occur&#xD;
        in up to 70% of aSAH cases, and in two thirds of those cases DCI develops, thus increasing&#xD;
        the mortality rate up to 50%. Every year up to 770 000 people suffer from aSAH and receive&#xD;
        neurosurgical treatment. Because of a large amount of factors (blood leak volume and its&#xD;
        distribution in the subarachnoid space, reactivity of cerebral blood vessels, biochemical&#xD;
        blood composition and demographical factors) and their complex interactions to contribute the&#xD;
        development of CV/DCI, currently there are no reliable methods and technologies allowing&#xD;
        reliably prediction of the consequences of SAH.&#xD;
  &#xD;
        For a more effective treatment of aSAH patients an innovative method for early warning of CV&#xD;
        and DCI phenomena is offered. The method is based on identifying of the associations of&#xD;
        different physiological modalities and prognostic factors with the SAH patients' outcome&#xD;
        (factors the obtained from CT images analysis, numerical modelling of SAH evolution and&#xD;
        multimodal cerebral hemodynamics monitoring).&#xD;
  &#xD;
        The goal of this observational study is to learn about the possibility to predict clinical&#xD;
        course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of&#xD;
        clinical data available in early pre-vasospasm phase.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography&#xD;
             Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be&#xD;
             used to predict development of cerebral vasospasms, delayed cerebral ischemia and&#xD;
             patients' outcome.&#xD;
  &#xD;
          -  What biomarkers retrieved from transcranial Doppler examinations in early pre-vasospasm&#xD;
             can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and&#xD;
             patients' outcome.&#xD;
  &#xD;
          -  What biomarkers retrieved from multimodal physiological monitoring in early pre&#xD;
             vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral&#xD;
             ischemia and patients' outcome.&#xD;
  &#xD;
          -  What is impact of other clinical data (blood test results, age, gender, etc.) into&#xD;
             development of cerebral vasospasms, delayed cerebral ischemia.&#xD;
  &#xD;
        Study objectives:&#xD;
  &#xD;
          1. To perform retrospective analysis neuroradiological examination data (CT/CTA images) of&#xD;
             patients who experienced spontaneous aSAH, by identifying factors that allow early&#xD;
             prediction of CV and DCI&#xD;
  &#xD;
          2. To perform retrospective analysis of the collected data of multimodal brain&#xD;
             physiological monitoring (intracranial pressure, arterial blood pressure, cerebral blood&#xD;
             flow velocity, heart rate) by determining the factors that allow to predict CV and DCI.&#xD;
  &#xD;
          3. To perform retrospective analysis of other clinical data (blood test results),&#xD;
             demographic data (gender, age) and their impact on development of CV and DCI.&#xD;
  &#xD;
          4. To develop the algorithm of predicting of CV, DCI and patients' outcome based on the&#xD;
             accumulated neuroradiological examination and multimodal monitoring data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 21, 2021</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cerebral vasospasms</measure>
      <time_frame>CTA is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary</time_frame>
      <description>Cerebral vasospasms are diagnosed by performing Computed Tomography Angiography (CTA) according to reduced diameters of cerebral arteries.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Delayed cerebral ischemia</measure>
      <time_frame>CT is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary</time_frame>
      <description>Delayed cerebral ischemia is diagnosed by performing Computed Tomography (CT)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient outcome</measure>
      <time_frame>GOS is evaluated at discharge from hospital and after 30 days after SAH</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>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Subarachnoid Hemorrhage, Aneurysmal</condition>
    <condition>Vasospasm, Cerebral</condition>
    <condition>Ischemia</condition>
    <condition>Outcome, Fatal</condition>
    <arm_group>
      <arm_group_label>Subarachnoid hemorrhage (SAH) patients</arm_group_label>
      <description>Patients after aneurysmal subarachnoid hemorrhage who received routine treatment (aneurysm clipping surgery, post operative care and multimodal monitoring in ICU).</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Computed Tomography (CT) and Computed Tomography Angiography (CTA)</intervention_name>
      <description>CT and CTA examinations are performed as a routine procedure to evaluate SAH severity and to diagnose cerebral vasospams and delayed cerebral ischemia.</description>
      <arm_group_label>Subarachnoid hemorrhage (SAH) patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Multimodal physiological 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) measured in middle cerebral artery and heart rate.&#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>
      <arm_group_label>Subarachnoid hemorrhage (SAH) patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will include patients treated at Vilnius University Hospital Santaros Klinikos&#xD;
          that undergo brain surgery after subarachnoid hemorrhage (SAH) and routine post-operative&#xD;
          treatment in ICU.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subarachnoid hemorrhage patients who require SAH surgery and post-operative routine&#xD;
               treatment.&#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, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University</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 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>subarachnoid hemorrhage</keyword>
    <keyword>delayed cerebral ischemia</keyword>
    <keyword>computed tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Subarachnoid Hemorrhage</mesh_term>
      <mesh_term>Brain Ischemia</mesh_term>
      <mesh_term>Cerebral Infarction</mesh_term>
      <mesh_term>Vasospasm, Intracranial</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
      <mesh_term>Ischemia</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/NCT06006975
  org study id: EWoDCI ver.C
  secondary id: 01.2.2-LMT-K-718-03-0091
  nct id: NCT06006975
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the possibility to predict clinical
        course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of
        clinical data available in early pre-vasospasm phase.
  
        The main questions it aims to answer are:
  
          -  What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography
             Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be
             used to predict development of cerebral vasospasms, delayed cerebral ischemia and
             patients' outcome.
  
          -  What biomarkers retrieved from transcranial Doppler examinations in early pre vasospasm
             can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and
             patients' outcome.
  
          -  What biomarkers retrieved from multimodal physiological monitoring in early pre
             vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral
             ischemia and patients' outcome.
  
          -  What is impact of other clinical data (blood test results, age, gender, etc.) on
             development of cerebral vasospasms and delayed cerebral ischemia.
  An adequate timely prognosis of cerebral vasospasms and delayed cerebral ischemia (DCI)
        occuring after spontaneous aneurysmal subarachnoid haemorrhage (aSAH), is vitally essential
        to selecting an individualized and timely treatment strategy. Cerebral vasospasms (CV) occur
        in up to 70% of aSAH cases, and in two thirds of those cases DCI develops, thus increasing
        the mortality rate up to 50%. Every year up to 770 000 people suffer from aSAH and receive
        neurosurgical treatment. Because of a large amount of factors (blood leak volume and its
        distribution in the subarachnoid space, reactivity of cerebral blood vessels, biochemical
        blood composition and demographical factors) and their complex interactions to contribute the
        development of CV/DCI, currently there are no reliable methods and technologies allowing
        reliably prediction of the consequences of SAH.
  
        For a more effective treatment of aSAH patients an innovative method for early warning of CV
        and DCI phenomena is offered. The method is based on identifying of the associations of
        different physiological modalities and prognostic factors with the SAH patients' outcome
        (factors the obtained from CT images analysis, numerical modelling of SAH evolution and
        multimodal cerebral hemodynamics monitoring).
  
        The goal of this observational study is to learn about the possibility to predict clinical
        course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of
        clinical data available in early pre-vasospasm phase.
  
        The main questions it aims to answer are:
  
          -  What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography
             Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be
             used to predict development of cerebral vasospasms, delayed cerebral ischemia and
             patients' outcome.
  
          -  What biomarkers retrieved from transcranial Doppler examinations in early pre-vasospasm
             can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and
             patients' outcome.
  
          -  What biomarkers retrieved from multimodal physiological monitoring in early pre
             vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral
             ischemia and patients' outcome.
  
          -  What is impact of other clinical data (blood test results, age, gender, etc.) into
             development of cerebral vasospasms, delayed cerebral ischemia.
  
        Study objectives:
  
          1. To perform retrospective analysis neuroradiological examination data (CT/CTA images) of
             patients who experienced spontaneous aSAH, by identifying factors that allow early
             prediction of CV and DCI
  
          2. To perform retrospective analysis of the collected data of multimodal brain
             physiological monitoring (intracranial pressure, arterial blood pressure, cerebral blood
             flow velocity, heart rate) by determining the factors that allow to predict CV and DCI.
  
          3. To perform retrospective analysis of other clinical data (blood test results),
             demographic data (gender, age) and their impact on development of CV and DCI.
  
          4. To develop the algorithm of predicting of CV, DCI and patients' outcome based on the
             accumulated neuroradiological examination and multimodal monitoring data.
  observational model: Cohort
  time perspective: Retrospective
  measure: Cerebral vasospasms
  time frame: CTA is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary
  description: Cerebral vasospasms are diagnosed by performing Computed Tomography Angiography (CTA) according to reduced diameters of cerebral arteries.
  measure: Delayed cerebral ischemia
  time frame: CT is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary
  description: Delayed cerebral ischemia is diagnosed by performing Computed Tomography (CT)
  measure: Patient outcome
  time frame: GOS is evaluated at discharge from hospital and after 30 days after SAH
  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
  arm group label: Subarachnoid hemorrhage (SAH) patients
  description: Patients after aneurysmal subarachnoid hemorrhage who received routine treatment (aneurysm clipping surgery, post operative care and multimodal monitoring in ICU).
  intervention type: Radiation
  intervention name: Computed Tomography (CT) and Computed Tomography Angiography (CTA)
  description: CT and CTA examinations are performed as a routine procedure to evaluate SAH severity and to diagnose cerebral vasospams and delayed cerebral ischemia.
  arm group label: Subarachnoid hemorrhage (SAH) patients
  intervention type: Diagnostic Test
  intervention name: Multimodal physiological 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) measured in middle cerebral artery and heart rate.
  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.
  arm group label: Subarachnoid hemorrhage (SAH) patients
  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, Prof. Dr.
  role: Principal Investigator
  affiliation: Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University
  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: Subarachnoid Hemorrhage
  mesh term: Brain Ischemia
  mesh term: Cerebral Infarction
  mesh term: Vasospasm, Intracranial
  mesh term: Hemorrhage
  mesh term: Ischemia
  sharing ipd: No