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/NCT05968911</url>
    </required_header>
    <id_info>
      <org_study_id>ABI_UVN</org_study_id>
      <nct_id>NCT05968911</nct_id>
    </id_info>
    <brief_title>Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury</brief_title>
    <official_title>Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Charles University, Czech Republic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Charles University, Czech Republic</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 prediction of the final neurological and functional status of patients with acquired&#xD;
        brain injury remains very uncertain despite the findings of current medicine. The aim of the&#xD;
        study is to evaluate the clinical outcomes in patients with the most severe degree of brain&#xD;
        injury hospitalized in the long-term intensive care unit of the Military University Hospital&#xD;
        Prague.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The prediction of the final neurological and functional status of patients with acquired&#xD;
        brain injury remains very uncertain despite the findings of current medicine. Current medical&#xD;
        knowledge is particularly limited in patients with the most severe brain injury who had to be&#xD;
        tracheostomized and admitted to long-term intensive care unit. In the Czech Republic, there&#xD;
        is a complete lack of data on clinical outcomes in these patients.&#xD;
  &#xD;
        Some recent studies has not confirmed the long-standing better outcome in patients with&#xD;
        traumatic brain injury compared to non-traumatic etiologies. The aim of the study is to&#xD;
        evaluate the clinical outcomes in patients with the most severe degree of brain injury&#xD;
        hospitalized in the long-term intensive care unit of the Military University Hospital Prague.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</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>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Level of consciousness achieved</measure>
      <time_frame>three months</time_frame>
      <description>Initial Glasgow coma scale (GCS) and GCS at discharge. Minimal points 3, maximal point 15. The higher the score the better the outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of self-sufficiency</measure>
      <time_frame>three months</time_frame>
      <description>Initial level of self-sufficiency and self-sufficiency at discharge using Barthel score.&#xD;
  0-100 points. A patient scoring 100 points is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs.&#xD;
  A score of 0 means that the patient does not meet any of the activities described above.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of survival after discharge from intensive care.</measure>
      <time_frame>three months</time_frame>
      <description>Length of survival after discharge from intensive care. In days.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Acquired Brain Injury</condition>
    <arm_group>
      <arm_group_label>Trauma brain injury</arm_group_label>
      <description>Patients with acquired brain injury of traumatic etiology.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-trauma brain injury</arm_group_label>
      <description>Patients with acquired brain injury of non-traumatic etiology.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients hospitalized in the long-term intensive care unit of the University Hospital&#xD;
          Prague in years 2015-2022 with acquired brain injury of the five most common etiologies&#xD;
          (traumatic injury, ischemic stroke, intracerebral hemorrhage, subarachnoid haemorrhage,&#xD;
          anoxic injury), whose initial Glasgow Coma Scale was less than 8 points and were&#xD;
          tracheostomized due to persistent impairment of consciousness.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Acquired brain injury&#xD;
  &#xD;
            -  Initial Glasgow Coma Scale (GCS) score less than 8 points&#xD;
  &#xD;
            -  Tracheostomy for persistent impairment of consciousness&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  none&#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>Ilona Trtíková, Mgr., Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ilona Trtíková, Mgr., Ph.D.</last_name>
      <phone>+420224965613</phone>
      <email>ilona.trtikova@clf1.cz</email>
    </overall_contact>
    <location>
      <facility>
        <name>Military University Hospital Prague</name>
        <address>
          <city>Praha</city>
          <zip>16209</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michal Soták, M.D., Ph.D.</last_name>
        <phone>+420973202999</phone>
        <email>michal.sotak@uvn.cz</email>
      </contact>
      <contact_backup>
        <last_name>Jan Votava, M.D.</last_name>
        <phone>+420973202999</phone>
        <email>jan.votava@uvn.cz</email>
      </contact_backup>
      <investigator>
        <last_name>Jan Votava, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <reference>
      <citation>Wabl R, Williamson CA, Pandey AS, Rajajee V. Long-term and delayed functional recovery in patients with severe cerebrovascular and traumatic brain injury requiring tracheostomy. J Neurosurg. 2018 Jul 6;131(1):114-121. doi: 10.3171/2018.2.JNS173247.</citation>
      <PMID>29979120</PMID>
    </reference>
    <reference>
      <citation>Magliacano A, De Bellis F, Panico F, Sagliano L, Trojano L, Sandroni C, Estraneo A. Long-term clinical evolution of patients with prolonged disorders of consciousness due to severe anoxic brain injury: A meta-analytic study. Eur J Neurol. 2023 May 29. doi: 10.1111/ene.15899. Online ahead of print.</citation>
      <PMID>37246500</PMID>
    </reference>
    <reference>
      <citation>Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.</citation>
      <PMID>7818633</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
      <investigator_full_name>Michal Soták</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>acquired brain injury</keyword>
    <keyword>consciousness disorders</keyword>
    <keyword>prognosis</keyword>
    <keyword>persistent vegetative state</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT05968911
  org study id: ABI_UVN
  nct id: NCT05968911
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The prediction of the final neurological and functional status of patients with acquired
        brain injury remains very uncertain despite the findings of current medicine. The aim of the
        study is to evaluate the clinical outcomes in patients with the most severe degree of brain
        injury hospitalized in the long-term intensive care unit of the Military University Hospital
        Prague.
  The prediction of the final neurological and functional status of patients with acquired
        brain injury remains very uncertain despite the findings of current medicine. Current medical
        knowledge is particularly limited in patients with the most severe brain injury who had to be
        tracheostomized and admitted to long-term intensive care unit. In the Czech Republic, there
        is a complete lack of data on clinical outcomes in these patients.
  
        Some recent studies has not confirmed the long-standing better outcome in patients with
        traumatic brain injury compared to non-traumatic etiologies. The aim of the study is to
        evaluate the clinical outcomes in patients with the most severe degree of brain injury
        hospitalized in the long-term intensive care unit of the Military University Hospital Prague.
  observational model: Other
  time perspective: Retrospective
  measure: Level of consciousness achieved
  time frame: three months
  description: Initial Glasgow coma scale (GCS) and GCS at discharge. Minimal points 3, maximal point 15. The higher the score the better the outcome.
  measure: Level of self-sufficiency
  time frame: three months
  description: Initial level of self-sufficiency and self-sufficiency at discharge using Barthel score.
  0-100 points. A patient scoring 100 points is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs.
  A score of 0 means that the patient does not meet any of the activities described above.
  measure: Length of survival after discharge from intensive care.
  time frame: three months
  description: Length of survival after discharge from intensive care. In days.
  arm group label: Trauma brain injury
  description: Patients with acquired brain injury of traumatic etiology.
  arm group label: Non-trauma brain injury
  description: Patients with acquired brain injury of non-traumatic etiology.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ilona Trtíková, Mgr., Ph.D.
  role: Study Chair
  affiliation: CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE
  last name: Ilona Trtíková, Mgr., Ph.D.
  phone: +420224965613
  email: ilona.trtikova@clf1.cz
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Czechia
  citation: Wabl R, Williamson CA, Pandey AS, Rajajee V. Long-term and delayed functional recovery in patients with severe cerebrovascular and traumatic brain injury requiring tracheostomy. J Neurosurg. 2018 Jul 6;131(1):114-121. doi: 10.3171/2018.2.JNS173247.
  PMID: 29979120
  citation: Magliacano A, De Bellis F, Panico F, Sagliano L, Trojano L, Sandroni C, Estraneo A. Long-term clinical evolution of patients with prolonged disorders of consciousness due to severe anoxic brain injury: A meta-analytic study. Eur J Neurol. 2023 May 29. doi: 10.1111/ene.15899. Online ahead of print.
  PMID: 37246500
  citation: Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.
  PMID: 7818633
  responsible party type: Principal Investigator
  investigator affiliation: Charles University, Czech Republic
  investigator full name: Michal Soták
  investigator title: Principal Investigator
  mesh term: Brain Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No