<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/NCT03027453</url>
  </required_header>
  <id_info>
    <org_study_id>B-SPATIAL</org_study_id>
    <nct_id>NCT03027453</nct_id>
  </id_info>
  <brief_title>Berlin - SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up</brief_title>
  <acronym>B-SPATIAL</acronym>
  <official_title>Berlin - Specific Acute Treatment in Ischemic or Haemorrhagic Stroke With Long Term Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Berliner Feuerwehr</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bundeswehrkrankenhaus Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DRK-Kliniken Berlin Köpenick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Evangelisches Krankenhaus Königin Elisabeth Herzberge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helios Klinikum Berlin-Buch</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jüdisches Krankenhaus Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Park-Klinik Weissensee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Schlosspark-Klinik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Unfallkrankenhaus Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vivantes Auguste-Viktoria-Klinikum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vivantes Klinikum im Friedrichshain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vivantes Humboldt-Klinikum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vivantes Clinic Neukölln</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vivantes Klinikum Spandau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific&#xD;
      Treatments such as endovascular treatment. It will also enable the participating hospitals to&#xD;
      compare the quality of care of their facility. At the same time, B-SPATIAL will provide an&#xD;
      opportunity of scientific evaluation of new therapeutic procedures or specific treatments in&#xD;
      stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous&#xD;
      thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will&#xD;
      allow for an identification of key quality indicators that assure valid quality assessment&#xD;
      aiming at a reduced documentation load for future quality management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background&#xD;
&#xD;
           Quality assessment of acute stroke care is organized in regional stroke registries in&#xD;
           Germany - for the federal state of Berlin in the Berlin Stroke Registry (BSR). The&#xD;
           current documentation of the Berlin Stroke Registry is focused on the documentation of&#xD;
           process quality in participating hospitals.&#xD;
&#xD;
           So far, outcome quality is only assessed by surrogate parameters such as complications&#xD;
           and mortality during in-hospital stay. However, according to consensus recommendations,&#xD;
           disability-free survival versus death and dependency is the most important outcome&#xD;
           measure after acute stroke. Because of the high variability of the clinical course after&#xD;
           stroke, this outcome is generally assessed after three months by using the modified&#xD;
           Rankin Scale (mRS).&#xD;
&#xD;
        2. Motivation&#xD;
&#xD;
           In early 2015, several published trials showed that mechanical thrombectomy improves the&#xD;
           prognosis of ischemic stroke patients with acute large artery occlusion of proximal&#xD;
           brain supplying arteries. Currently, this invasive catheter based treatment is not&#xD;
           available in many hospitals with acute Stroke Unit. It is likely that the quality of&#xD;
           technical procedures depends on the expertise and experience of treating&#xD;
           interventionalists. Current studies suggest a close relationship between effectiveness&#xD;
           of the approach and time to treatment, similar to intravenous thrombolysis. This time&#xD;
           dependency makes prehospital triage more challenging because selection of the&#xD;
           appropriate facility is likely to influence patient outcome.&#xD;
&#xD;
           Intracerebral hemorrhage (ICH) is less frequent than ischemic stroke but is associated&#xD;
           with worse prognosis. Recent studies suggest that blood pressure lowering may improve&#xD;
           prognosis if started during the hyperacute phase of ICH. With limited scientific&#xD;
           evidence, many patients undergo neurosurgical intervention. It remains unclear whether&#xD;
           delivery of hemorrhagic stroke patients to hospitals with neurosurgery leads to better&#xD;
           outcome.&#xD;
&#xD;
           Hence, pre-hospital care with delivery to more or less specialized clinical facilities&#xD;
           may have a crucial impact for both subtypes of stroke. The introduction of specialized&#xD;
           stroke ambulances (Stroke Emergency Mobiles, STEMOs) opens new avenues for pre-hospital&#xD;
           stroke diagnosis, treatment and patient triage. The effects of STEMO care are planned to&#xD;
           be assessed by the parallel B-PROUD-Study (NCT02869386).&#xD;
&#xD;
        3. Purpose&#xD;
&#xD;
           The B-SPATIAL-Registry will provide a tool of quality assessment for new specific&#xD;
           treatments. It will also enable the participating hospitals to compare the quality of&#xD;
           care of their own facility.&#xD;
&#xD;
           Because this registry represents an quality monitoring initiative, the telephone&#xD;
           follow-up is collected with an opt-out solution, allowing to decline participation after&#xD;
           the patients are informed on the follow-up telephone call at discharge and through a&#xD;
           letter send one month prior to the actual call. As written informed consent is not&#xD;
           required, this method will facilitate a high follow-up rate particularly in patients&#xD;
           with severe neurological deficits or treated in non-academic hospitals.&#xD;
&#xD;
           In B-SPATIAL we want to identify key quality indicators that assure valid quality&#xD;
           assessment despite reduced documentation load in future quality management.&#xD;
&#xD;
           Specific Aims of the registry:&#xD;
&#xD;
             -  Assessment of proportions of patients receiving specific treatments (based on total&#xD;
                number of eligible)&#xD;
&#xD;
             -  Evaluation of treatment specific indicators for process quality including&#xD;
                pre-hospital care&#xD;
&#xD;
             -  Evaluation of outcome quality (survival, level of disability and quality of life&#xD;
                after 3 months)&#xD;
&#xD;
           Pre-specified analyses:&#xD;
&#xD;
           Ischemic stroke&#xD;
&#xD;
             -  Intravenous hospital based tPA rate in treatment candidates&#xD;
&#xD;
             -  Time to treatment in intravenous tPA&#xD;
&#xD;
             -  Rate of secondary interhospital referral&#xD;
&#xD;
             -  Proportions of patients receiving endovascular thrombectomy&#xD;
&#xD;
             -  Time to groin puncture and reperfusion in patients with endovascular thrombectomy&#xD;
&#xD;
             -  Proportions of used devices&#xD;
&#xD;
             -  Proportions of patients with general/non general anesthesia (conscious sedation)&#xD;
&#xD;
             -  Secondary intracranial hemorrhage&#xD;
&#xD;
             -  Functional outcome according to mRS at 3 months&#xD;
&#xD;
           Hemorrhagic stroke&#xD;
&#xD;
             -  Time to start of intravenous antihypertensive treatment&#xD;
&#xD;
             -  Time to start of PCC in patients with OAC or specific reversal of NOACs&#xD;
&#xD;
             -  Rate of surgical treatments&#xD;
&#xD;
             -  Rate of secondary interhospital referral&#xD;
&#xD;
             -  Enlargement and final volume of ICH&#xD;
&#xD;
             -  Functional outcome according to mRS at 3 months&#xD;
&#xD;
           Data sources&#xD;
&#xD;
           The documentation will include pre-hospital, in-hospital and post-discharge processes&#xD;
           such as:&#xD;
&#xD;
             -  Emergency medical service (EMS)&#xD;
&#xD;
             -  Acute in-hospital stay&#xD;
&#xD;
             -  Follow-up (first choice: telephone, second choice: written questionnaire, third&#xD;
                choice: FU regarding vital status from registration offices)&#xD;
&#xD;
        4. Patients&#xD;
&#xD;
           In order to ensure valid analysis of treatment rates in participating hospitals,&#xD;
           patients will be included according to the following inclusion criteria:&#xD;
&#xD;
             -  Patients with hospital main discharge diagnoses according to ICD 10: Ischemic&#xD;
                stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and&#xD;
&#xD;
                  -  Onset of symptoms within 6 hours of hospital arrival&#xD;
&#xD;
                  -  In patients with TIA diagnosis: Persistent neurological symptoms at hospital&#xD;
                     arrival (emergency department documentation)&#xD;
&#xD;
             -  Patients with main discharge diagnosis of intracranial hemorrhage and hospital&#xD;
                admission within 6 hours of stroke onset.&#xD;
&#xD;
             -  Patients with other main discharge diagnoses and documented intravenous&#xD;
                thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics&#xD;
&#xD;
        5. Data documentation&#xD;
&#xD;
             -  Data will be entered in all participating hospitals via remote access to the&#xD;
                databank&#xD;
&#xD;
             -  Data will be entered with pseudonyms but identification will only be possible in&#xD;
                local hospitals via register-logs that will be safely stored in the hospitals.&#xD;
&#xD;
        6. Databank characteristics&#xD;
&#xD;
             -  For data entry, we will use the REDcap databank software with access from all&#xD;
                participating hospitals.&#xD;
&#xD;
             -  Dedicated computers will be used and safely stored in participating hospitals.&#xD;
                Encryption and password algorithms will protect the remote access to the databank.&#xD;
&#xD;
             -  The registry databank will be stored and hosted on a protected server of the&#xD;
                Charité IT department.&#xD;
&#xD;
             -  For statistical evaluation, the REDcap databank will be exported in an SPSS-based&#xD;
                data format, stored on the server of the Center for Stroke Research Berlin (CSB).&#xD;
&#xD;
        7. Responsibilities&#xD;
&#xD;
             -  Data entry: Study nurses in participating hospitals&#xD;
&#xD;
             -  Databank in Charité IT-center: Charité IT department and databank manager of the&#xD;
                Clinical Research Units&#xD;
&#xD;
             -  Scientific evaluation: PI of CSB (Jessica L.Rohmann in cooperation with Heinrich J.&#xD;
                Audebert, Martin Ebinger and Christian Nolte)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">April 2021</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>Modified Rankin Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of functional outcome over the entire range of the modified Rankin Scale</description>
  </primary_outcome>
  <enrollment type="Actual">15246</enrollment>
  <condition>Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Stroke patients (ischemic and haemorrhagic)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke&#xD;
             (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and&#xD;
&#xD;
               -  Onset of symptoms within 6 hours of hospital arrival&#xD;
&#xD;
               -  In patients with TIA diagnosis: Persistent neurological symptoms at hospital&#xD;
                  arrival (emergency department documentation)&#xD;
&#xD;
          2. Patients with main discharge diagnosis of intracranial hemorrhage and symptom onset&#xD;
             within 6 hours of hospital admission&#xD;
&#xD;
          3. Patients with other main discharge diagnoses and documented intravenous thrombolysis&#xD;
             (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics&#xD;
&#xD;
        Exclusion Critera:&#xD;
&#xD;
          -  Symptom remission before EMS arrival or hospital arrival (if no EMS Transport)&#xD;
&#xD;
          -  Primary subarachnoid hemorrhage&#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>Jessica L Rohmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Stroke Research Berlin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Stroke Research Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.</citation>
    <PMID>24756512</PMID>
  </reference>
  <reference>
    <citation>Krebes S, Ebinger M, Baumann AM, Kellner PA, Rozanski M, Doepp F, Sobesky J, Gensecke T, Leidel BA, Malzahn U, Wellwood I, Heuschmann PU, Audebert HJ. Development and validation of a dispatcher identification algorithm for stroke emergencies. Stroke. 2012 Mar;43(3):776-81. doi: 10.1161/STROKEAHA.111.634980. Epub 2012 Jan 5.</citation>
    <PMID>22223240</PMID>
  </reference>
  <reference>
    <citation>Ebinger M, Fiebach JB, Audebert HJ. Mobile computed tomography: prehospital diagnosis and treatment of stroke. Curr Opin Neurol. 2015 Feb;28(1):4-9. doi: 10.1097/WCO.0000000000000165.</citation>
    <PMID>25490196</PMID>
  </reference>
  <reference>
    <citation>Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.</citation>
    <PMID>25634000</PMID>
  </reference>
  <reference>
    <citation>Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.</citation>
    <PMID>27430529</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>September 10, 2022</last_update_submitted>
  <last_update_submitted_qc>September 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Heinrich J Audebert</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03027453
org study id: B-SPATIAL
nct id: NCT03027453
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific
      Treatments such as endovascular treatment. It will also enable the participating hospitals to
      compare the quality of care of their facility. At the same time, B-SPATIAL will provide an
      opportunity of scientific evaluation of new therapeutic procedures or specific treatments in
      stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous
      thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will
      allow for an identification of key quality indicators that assure valid quality assessment
      aiming at a reduced documentation load for future quality management.
1. Background

           Quality assessment of acute stroke care is organized in regional stroke registries in
           Germany - for the federal state of Berlin in the Berlin Stroke Registry (BSR). The
           current documentation of the Berlin Stroke Registry is focused on the documentation of
           process quality in participating hospitals.

           So far, outcome quality is only assessed by surrogate parameters such as complications
           and mortality during in-hospital stay. However, according to consensus recommendations,
           disability-free survival versus death and dependency is the most important outcome
           measure after acute stroke. Because of the high variability of the clinical course after
           stroke, this outcome is generally assessed after three months by using the modified
           Rankin Scale (mRS).

        2. Motivation

           In early 2015, several published trials showed that mechanical thrombectomy improves the
           prognosis of ischemic stroke patients with acute large artery occlusion of proximal
           brain supplying arteries. Currently, this invasive catheter based treatment is not
           available in many hospitals with acute Stroke Unit. It is likely that the quality of
           technical procedures depends on the expertise and experience of treating
           interventionalists. Current studies suggest a close relationship between effectiveness
           of the approach and time to treatment, similar to intravenous thrombolysis. This time
           dependency makes prehospital triage more challenging because selection of the
           appropriate facility is likely to influence patient outcome.

           Intracerebral hemorrhage (ICH) is less frequent than ischemic stroke but is associated
           with worse prognosis. Recent studies suggest that blood pressure lowering may improve
           prognosis if started during the hyperacute phase of ICH. With limited scientific
           evidence, many patients undergo neurosurgical intervention. It remains unclear whether
           delivery of hemorrhagic stroke patients to hospitals with neurosurgery leads to better
           outcome.

           Hence, pre-hospital care with delivery to more or less specialized clinical facilities
           may have a crucial impact for both subtypes of stroke. The introduction of specialized
           stroke ambulances (Stroke Emergency Mobiles, STEMOs) opens new avenues for pre-hospital
           stroke diagnosis, treatment and patient triage. The effects of STEMO care are planned to
           be assessed by the parallel B-PROUD-Study (NCT02869386).

        3. Purpose

           The B-SPATIAL-Registry will provide a tool of quality assessment for new specific
           treatments. It will also enable the participating hospitals to compare the quality of
           care of their own facility.

           Because this registry represents an quality monitoring initiative, the telephone
           follow-up is collected with an opt-out solution, allowing to decline participation after
           the patients are informed on the follow-up telephone call at discharge and through a
           letter send one month prior to the actual call. As written informed consent is not
           required, this method will facilitate a high follow-up rate particularly in patients
           with severe neurological deficits or treated in non-academic hospitals.

           In B-SPATIAL we want to identify key quality indicators that assure valid quality
           assessment despite reduced documentation load in future quality management.

           Specific Aims of the registry:

             -  Assessment of proportions of patients receiving specific treatments (based on total
                number of eligible)

             -  Evaluation of treatment specific indicators for process quality including
                pre-hospital care

             -  Evaluation of outcome quality (survival, level of disability and quality of life
                after 3 months)

           Pre-specified analyses:

           Ischemic stroke

             -  Intravenous hospital based tPA rate in treatment candidates

             -  Time to treatment in intravenous tPA

             -  Rate of secondary interhospital referral

             -  Proportions of patients receiving endovascular thrombectomy

             -  Time to groin puncture and reperfusion in patients with endovascular thrombectomy

             -  Proportions of used devices

             -  Proportions of patients with general/non general anesthesia (conscious sedation)

             -  Secondary intracranial hemorrhage

             -  Functional outcome according to mRS at 3 months

           Hemorrhagic stroke

             -  Time to start of intravenous antihypertensive treatment

             -  Time to start of PCC in patients with OAC or specific reversal of NOACs

             -  Rate of surgical treatments

             -  Rate of secondary interhospital referral

             -  Enlargement and final volume of ICH

             -  Functional outcome according to mRS at 3 months

           Data sources

           The documentation will include pre-hospital, in-hospital and post-discharge processes
           such as:

             -  Emergency medical service (EMS)

             -  Acute in-hospital stay

             -  Follow-up (first choice: telephone, second choice: written questionnaire, third
                choice: FU regarding vital status from registration offices)

        4. Patients

           In order to ensure valid analysis of treatment rates in participating hospitals,
           patients will be included according to the following inclusion criteria:

             -  Patients with hospital main discharge diagnoses according to ICD 10: Ischemic
                stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and

                  -  Onset of symptoms within 6 hours of hospital arrival

                  -  In patients with TIA diagnosis: Persistent neurological symptoms at hospital
                     arrival (emergency department documentation)

             -  Patients with main discharge diagnosis of intracranial hemorrhage and hospital
                admission within 6 hours of stroke onset.

             -  Patients with other main discharge diagnoses and documented intravenous
                thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics

        5. Data documentation

             -  Data will be entered in all participating hospitals via remote access to the
                databank

             -  Data will be entered with pseudonyms but identification will only be possible in
                local hospitals via register-logs that will be safely stored in the hospitals.

        6. Databank characteristics

             -  For data entry, we will use the REDcap databank software with access from all
                participating hospitals.

             -  Dedicated computers will be used and safely stored in participating hospitals.
                Encryption and password algorithms will protect the remote access to the databank.

             -  The registry databank will be stored and hosted on a protected server of the
                Charité IT department.

             -  For statistical evaluation, the REDcap databank will be exported in an SPSS-based
                data format, stored on the server of the Center for Stroke Research Berlin (CSB).

        7. Responsibilities

             -  Data entry: Study nurses in participating hospitals

             -  Databank in Charité IT-center: Charité IT department and databank manager of the
                Clinical Research Units

             -  Scientific evaluation: PI of CSB (Jessica L.Rohmann in cooperation with Heinrich J.
                Audebert, Martin Ebinger and Christian Nolte)
observational model: Cohort
time perspective: Prospective
measure: Modified Rankin Scale
time frame: 3 months
description: Assessment of functional outcome over the entire range of the modified Rankin Scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica L Rohmann
role: Principal Investigator
affiliation: Center for Stroke Research Berlin
facility: 
country: Germany
citation: Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.
PMID: 24756512
citation: Krebes S, Ebinger M, Baumann AM, Kellner PA, Rozanski M, Doepp F, Sobesky J, Gensecke T, Leidel BA, Malzahn U, Wellwood I, Heuschmann PU, Audebert HJ. Development and validation of a dispatcher identification algorithm for stroke emergencies. Stroke. 2012 Mar;43(3):776-81. doi: 10.1161/STROKEAHA.111.634980. Epub 2012 Jan 5.
PMID: 22223240
citation: Ebinger M, Fiebach JB, Audebert HJ. Mobile computed tomography: prehospital diagnosis and treatment of stroke. Curr Opin Neurol. 2015 Feb;28(1):4-9. doi: 10.1097/WCO.0000000000000165.
PMID: 25490196
citation: Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.
PMID: 25634000
citation: Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.
PMID: 27430529
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Heinrich J Audebert
investigator title: Prof. Dr. med.
mesh term: Stroke
mesh term: Hemorrhagic Stroke
sharing ipd: No