<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/NCT02231060</url>
  </required_header>
  <id_info>
    <org_study_id>2014_A55</org_study_id>
    <nct_id>NCT02231060</nct_id>
  </id_info>
  <brief_title>Study for the Improvement of Long-Term Outcome Prediction in Patients in Coma After Cardiac Arrest</brief_title>
  <acronym>HOPE</acronym>
  <official_title>Hypoxia and Outcome Prediction in Early Stage Coma: Towards an Improvement of Clinical and Electrophysiological Predictors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Else Kröner Fresenius Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Augsburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinikum Ingolstadt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinikum Rosenheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Therapiezentrum Burgau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Schoen Clinic Bad Aibling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Schön Klinik München Schwabing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asklepios Stadtklinik Bad Tölz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Krankenhaus Barmherzige Brüder München</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roteskreuzklinikum München</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deutsches Herzzentrum Muenchen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of HOPE is to improve the accuracy of outcome prediction in&#xD;
      anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some&#xD;
      of the existing methods used for this purpose (e.g. somato-sensory evoked potentials). HOPE&#xD;
      is the first multicenter prospective cohort study on coma prognosis to control for the effect&#xD;
      of a possible self-fulfilling prophecy at the ICU and to cover the acute and&#xD;
      neurorehabilitation phases with a long-term follow-up longer than the usual three or six&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HOPE conducts a 2.5-year multicenter prospective cohort study in Germany on outcome&#xD;
      prediction in the early stages of coma caused by cerebral hypoxia-ischemia.&#xD;
&#xD;
      The main features of the project are:&#xD;
&#xD;
        -  Control for a self-fulfilling prophecy&#xD;
&#xD;
        -  Long-term follow-up (12 months) covering acute and neurorehabilitation phases&#xD;
&#xD;
        -  Use of sensitive measures of level of consciousness&#xD;
&#xD;
        -  Further in-depth and systematic examination of the predictive value of somato-sensory&#xD;
           evoked potentials (SSEP)&#xD;
&#xD;
      Using as a reference existing guidelines and previous research, we consider the following&#xD;
      factors to be predictors of a negative outcome with a high specificity of &gt; 90% with small&#xD;
      95% confidence intervals: loss of cortical N20 SEP potentials, loss of more than one brain&#xD;
      stem reflex, non-reactive EEG, or a NSE above 33 mcg/L. We refer to the presence of any of&#xD;
      these specific unfavourable test results during the ICU treatment as a &quot;negative predictor&quot;.&#xD;
      Therefore, our null hypothesis is that the probability of a favourable outcome, despite the&#xD;
      presence of a negative predictor, is &lt; 10%. We will use Simon's two-stage design. The null&#xD;
      hypothesis will be tested against a one-sided alternative. In the first stage, we will accrue&#xD;
      72 patients. If there are 8 or fewer good outcomes in these 72 patients, the study will be&#xD;
      discontinued because the null hypothesis could not be rejected. Otherwise, we will recruit&#xD;
      100 additional patients to gather a total of 172. The null hypothesis will be rejected if 28&#xD;
      or more favourable outcomes are observed in these 172 patients. This design yields a type I&#xD;
      error rate of 0.05 and power of 80% if the true response rate is 25%, i.e. if indeed 25% or&#xD;
      more patients have a favourable outcome despite a negative predictor. This calculation is&#xD;
      based on the assumption that 25% of the enrolled patients have at least one negative&#xD;
      predictor.&#xD;
&#xD;
      HOPE has seven data entry points (i.e. study visits).The primary endpoints are completion of&#xD;
      the follow-up period or patient death. HOPE collects clinical and demographic data in&#xD;
      accordance to Utstein-style recommendations. The most crucial part of the study is&#xD;
      determining the current level of consciousness by means of the revised version of the Coma&#xD;
      Recovery Scale (CRS-R). The CRS-R allows a precise categorization of the current level of&#xD;
      consciousness based on a structured and systematic clinical examination of auditory, visual,&#xD;
      motor, oromotor, communication and arousal functions. Other assessment instruments employed&#xD;
      yield information about functional outcome/ADL, neuropsychological performance, and&#xD;
      health-related quality of life.&#xD;
&#xD;
      Study centers will collect data prospectively following a data acquisition timeline (e.g. t0&#xD;
      to t6). Visits t0 to t2 will take place at acute-setting ICUs; visits t3 to t5 at&#xD;
      neurorehabilitation centers; and visit t6 at the patients' location of residence 12 months&#xD;
      after day 0. A manual and data dictionary will be provided to all centres along with the case&#xD;
      report forms (CRF). All study centers will send pseudonymized data weekly by certified mail&#xD;
      to the Central Study Centre (CSC) located at the Department of Neurology of the University of&#xD;
      Munich. All study centres, including the CSC, will check the data for completeness,&#xD;
      plausibility, accuracy, consistency and outliers. Legal representatives of coma patients, who&#xD;
      decline to participate, will be asked to provide data on socio-demographic variables and&#xD;
      reason for declining. The CSC will store the data at a database and will be responsible for&#xD;
      safeguarding and analysing it. Patients/Legal representatives will be asked to remain in the&#xD;
      study for a further follow-up. After completion of the follow-up period, datasets will be&#xD;
      irreversibly anonymised.&#xD;
&#xD;
      We will analyze the positive predictive value of a dichotomous prognostic marker (favorable&#xD;
      or unfavourable SSEP). For this purpose, we will use two definitions of favorable outcome,&#xD;
      i.e. a functional and a behavioral one. If outcome is defined with respect to independence in&#xD;
      daily life, we will use a modified Rankin Scale score of 0-3 (no symptoms - moderate&#xD;
      disability, but able to walk independently) to categorize a favorable functional outcome. In&#xD;
      the context of a catastrophic event such as cardiac arrest with high likelihood of permanent&#xD;
      VS, it is our experience that some patients and families consider regaining functional&#xD;
      communications skills also a favourable outcome. In a separate analysis, we will therefore&#xD;
      use the recovery of full consciousness as measured by the CRS-R to define a favorable&#xD;
      behavioral outcome. To analyse the effect of covariates on functional and behavioral&#xD;
      outcomes, we will use mixed effects regression models, including both fixed and random&#xD;
      effects. This method of analyzing longitudinal data is highly effective to examine change&#xD;
      trajectories with several unequally spaced waves of data. Covariates will be sociodemographic&#xD;
      variables, prognostic variables and treatment factors (e.g. use of therapeutic hypothermia),&#xD;
      adjusted for age and sex.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 6, 2018</completion_date>
  <primary_completion_date type="Actual">December 6, 2018</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Current level of consciousness as measured by the revised version of the Coma Recovery Scale (CRS-R)</measure>
    <time_frame>There are 6 CRS-R data entry points distributed within a 12-month period, namely, 2 time points at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.</time_frame>
    <description>The CRS-R allows a precise categorization of the current level of consciousness based on a structured and systematic clinical examination of auditory, visual, motor, oromotor, communication and arousal functions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Regaining of functional communication skills and optimal health-related quality of life</measure>
    <time_frame>Five data entry points distributed within a 12-month period, namely, 1 time point at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Anoxic-Ischemic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>AIE after Cardiac Arrest</arm_group_label>
    <description>Male and female patients with AIE following CA.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with anoxic-ischemic encephalopathy following cardiac arrest.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 85 years&#xD;
&#xD;
          -  Cause of admission to ICU: cardiac arrest (in or out of hospital)&#xD;
&#xD;
          -  Glasgow-Coma-Scale &lt; 9 at time of study enrolment (3 to 8 days after cardiac arrest)&#xD;
&#xD;
          -  Informed consent signed by legal guardian/next-of-kin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke (as it may interfere with SSEP testing)&#xD;
&#xD;
          -  Pre-existing coma/vegetative state/minimally conscious state&#xD;
&#xD;
          -  Terminal malignant disease&#xD;
&#xD;
          -  Survival in the next 12 months extremely unlikely&#xD;
&#xD;
          -  Existing advanced directive that demands cessation of therapy/life support&#xD;
&#xD;
          -  Palliative care/withdrawal of life support during treatment at the ICU&#xD;
&#xD;
          -  Barbiturate-induced general anesthesia during the first 3 days after cardiac arrest&#xD;
&#xD;
          -  Impossibility of assessing current level of consciousness with the Glasgow Coma Scale&#xD;
             due to a long-term deep sedation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Bender, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians-Universität München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Neurology, Asklepios Stadtklinik Bad Tölz</name>
      <address>
        <city>Bad Tölz</city>
        <state>Bavaria</state>
        <zip>83646</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Anesthesiology, University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>D-81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <state>Bayern</state>
        <zip>86009</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I. Medizinische Klinik, Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <state>Bayern</state>
        <zip>86009</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schön Klinik Bad Aibling</name>
      <address>
        <city>Bad Aibling</city>
        <state>Bayern</state>
        <zip>83043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapiezentrum Burgau</name>
      <address>
        <city>Burgau</city>
        <state>Bayern</state>
        <zip>89331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Klinik I und IV, Klinikum Ingolstadt</name>
      <address>
        <city>Ingolstadt</city>
        <state>Bayern</state>
        <zip>85021</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Klinik, Klinikum Ingolstadt</name>
      <address>
        <city>Ingolstadt</city>
        <state>Bayern</state>
        <zip>85021</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Muenchen</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brüder München</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>80639</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schön Klinik München Schwabing</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>80804</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal ICU, Medical Clinic and Polyclinic IV, University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Klinik und Poliklinik I, University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology</name>
      <address>
        <city>Munich</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Klinik, RoMed Klinikum Rosenheim</name>
      <address>
        <city>Rosenheim</city>
        <state>Bayern</state>
        <zip>83022</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4451883/</url>
    <description>Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study</description>
  </link>
  <reference>
    <citation>Lopez-Rolon A, Bender A; Project HOPE Investigator Group. Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study. BMC Neurol. 2015 May 15;15:82. doi: 10.1186/s12883-015-0337-x.</citation>
    <PMID>25971341</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Andreas Bender</investigator_full_name>
    <investigator_title>Professor, Doctor Medicinae (Prof. Dr. med.)</investigator_title>
  </responsible_party>
  <keyword>Outcome Prediction</keyword>
  <keyword>Anoxic-Ischemic Encephalopathy</keyword>
  <keyword>Coma</keyword>
  <keyword>Vegetative State</keyword>
  <keyword>Minimally Conscious State</keyword>
  <keyword>Chronic Disorders of Consciousness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02231060
org study id: 2014_A55
nct id: NCT02231060
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has dmc: Yes
The primary objective of HOPE is to improve the accuracy of outcome prediction in
      anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some
      of the existing methods used for this purpose (e.g. somato-sensory evoked potentials). HOPE
      is the first multicenter prospective cohort study on coma prognosis to control for the effect
      of a possible self-fulfilling prophecy at the ICU and to cover the acute and
      neurorehabilitation phases with a long-term follow-up longer than the usual three or six
      months.
HOPE conducts a 2.5-year multicenter prospective cohort study in Germany on outcome
      prediction in the early stages of coma caused by cerebral hypoxia-ischemia.

      The main features of the project are:

        -  Control for a self-fulfilling prophecy

        -  Long-term follow-up (12 months) covering acute and neurorehabilitation phases

        -  Use of sensitive measures of level of consciousness

        -  Further in-depth and systematic examination of the predictive value of somato-sensory
           evoked potentials (SSEP)

      Using as a reference existing guidelines and previous research, we consider the following
      factors to be predictors of a negative outcome with a high specificity of > 90% with small
      95% confidence intervals: loss of cortical N20 SEP potentials, loss of more than one brain
      stem reflex, non-reactive EEG, or a NSE above 33 mcg/L. We refer to the presence of any of
      these specific unfavourable test results during the ICU treatment as a "negative predictor".
      Therefore, our null hypothesis is that the probability of a favourable outcome, despite the
      presence of a negative predictor, is < 10%. We will use Simon's two-stage design. The null
      hypothesis will be tested against a one-sided alternative. In the first stage, we will accrue
      72 patients. If there are 8 or fewer good outcomes in these 72 patients, the study will be
      discontinued because the null hypothesis could not be rejected. Otherwise, we will recruit
      100 additional patients to gather a total of 172. The null hypothesis will be rejected if 28
      or more favourable outcomes are observed in these 172 patients. This design yields a type I
      error rate of 0.05 and power of 80% if the true response rate is 25%, i.e. if indeed 25% or
      more patients have a favourable outcome despite a negative predictor. This calculation is
      based on the assumption that 25% of the enrolled patients have at least one negative
      predictor.

      HOPE has seven data entry points (i.e. study visits).The primary endpoints are completion of
      the follow-up period or patient death. HOPE collects clinical and demographic data in
      accordance to Utstein-style recommendations. The most crucial part of the study is
      determining the current level of consciousness by means of the revised version of the Coma
      Recovery Scale (CRS-R). The CRS-R allows a precise categorization of the current level of
      consciousness based on a structured and systematic clinical examination of auditory, visual,
      motor, oromotor, communication and arousal functions. Other assessment instruments employed
      yield information about functional outcome/ADL, neuropsychological performance, and
      health-related quality of life.

      Study centers will collect data prospectively following a data acquisition timeline (e.g. t0
      to t6). Visits t0 to t2 will take place at acute-setting ICUs; visits t3 to t5 at
      neurorehabilitation centers; and visit t6 at the patients' location of residence 12 months
      after day 0. A manual and data dictionary will be provided to all centres along with the case
      report forms (CRF). All study centers will send pseudonymized data weekly by certified mail
      to the Central Study Centre (CSC) located at the Department of Neurology of the University of
      Munich. All study centres, including the CSC, will check the data for completeness,
      plausibility, accuracy, consistency and outliers. Legal representatives of coma patients, who
      decline to participate, will be asked to provide data on socio-demographic variables and
      reason for declining. The CSC will store the data at a database and will be responsible for
      safeguarding and analysing it. Patients/Legal representatives will be asked to remain in the
      study for a further follow-up. After completion of the follow-up period, datasets will be
      irreversibly anonymised.

      We will analyze the positive predictive value of a dichotomous prognostic marker (favorable
      or unfavourable SSEP). For this purpose, we will use two definitions of favorable outcome,
      i.e. a functional and a behavioral one. If outcome is defined with respect to independence in
      daily life, we will use a modified Rankin Scale score of 0-3 (no symptoms - moderate
      disability, but able to walk independently) to categorize a favorable functional outcome. In
      the context of a catastrophic event such as cardiac arrest with high likelihood of permanent
      VS, it is our experience that some patients and families consider regaining functional
      communications skills also a favourable outcome. In a separate analysis, we will therefore
      use the recovery of full consciousness as measured by the CRS-R to define a favorable
      behavioral outcome. To analyse the effect of covariates on functional and behavioral
      outcomes, we will use mixed effects regression models, including both fixed and random
      effects. This method of analyzing longitudinal data is highly effective to examine change
      trajectories with several unequally spaced waves of data. Covariates will be sociodemographic
      variables, prognostic variables and treatment factors (e.g. use of therapeutic hypothermia),
      adjusted for age and sex.
observational model: Cohort
time perspective: Prospective
measure: Current level of consciousness as measured by the revised version of the Coma Recovery Scale (CRS-R)
time frame: There are 6 CRS-R data entry points distributed within a 12-month period, namely, 2 time points at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.
description: The CRS-R allows a precise categorization of the current level of consciousness based on a structured and systematic clinical examination of auditory, visual, motor, oromotor, communication and arousal functions.
measure: Regaining of functional communication skills and optimal health-related quality of life
time frame: Five data entry points distributed within a 12-month period, namely, 1 time point at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.
arm group label: AIE after Cardiac Arrest
description: Male and female patients with AIE following CA.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andreas Bender, MD
role: Principal Investigator
affiliation: Ludwig-Maximilians-Universität München
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country: Germany
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4451883/
description: Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study
citation: Lopez-Rolon A, Bender A; Project HOPE Investigator Group. Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study. BMC Neurol. 2015 May 15;15:82. doi: 10.1186/s12883-015-0337-x.
PMID: 25971341
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Andreas Bender
investigator title: Professor, Doctor Medicinae (Prof. Dr. med.)
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
sharing ipd: Undecided