<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/NCT03245866</url>
  </required_header>
  <id_info>
    <org_study_id>SwissSOS_0001</org_study_id>
    <nct_id>NCT03245866</nct_id>
  </id_info>
  <brief_title>Swiss Study on Subarachnoid Hemorrhage</brief_title>
  <acronym>Swiss-SOS</acronym>
  <official_title>Swiss Study on Subarachnoid Hemorrhage (Swiss-SOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kantonsspital Aarau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ospedale Regionale di Lugano</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Zürich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cantonal Hospital of St. Gallen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This registry was created to assess management parameters of patients treated for aneurysmal&#xD;
      subarachnoid hemorrhage in Switzerland. All Swiss hospitals with a neurosurgery department,&#xD;
      an intensive care unit and an interventional neuroradiology team that treat neurovascular&#xD;
      emergencies participate in the registry. Clinical parameters are entered into a common&#xD;
      database. This database will provide (1) a nationwide assessment of the current standard of&#xD;
      care and (2) the outcomes for patients in Switzerland including neuropsychological&#xD;
      assessments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview:&#xD;
&#xD;
      The management of aneurysmal subarachnoid hemorrhage (aSAH) in Switzerland has not been&#xD;
      assessed on a national level to date. The investigators united all comprehensive&#xD;
      neurovascular care centres in Switzerland to create a registry for aSAH. This registry helps&#xD;
      collect clinical and management data from different centres and pools it in one common&#xD;
      database. It may provide referring caregivers and healthcare providers with a critical tool&#xD;
      to assess the quality of care in a disease which has a high socio-economic burden. Moreover,&#xD;
      it may serve as a tool to foster scientific collaboration and address a number of remaining&#xD;
      questions about the management of aSAH in the future. Regarding SAH, data from the federal&#xD;
      statistics bureau of Switzerland are based strictly on ICD-10 codes provided by hospitals and&#xD;
      show an estimate of 13 per 100,000 in a population of roughly 8 million&#xD;
      (http://bfs.admin.ch). These numbers, however, are not referring to aneurismal SAH&#xD;
      exclusively and thus exceed the numbers which the investigators expect to obtain. The goal is&#xD;
      to obtain complete recruitment of SAH patients throughout Switzerland, and the goal is&#xD;
      therefore that assessment of incidence will be performed later on.&#xD;
&#xD;
      Data management:&#xD;
&#xD;
      Data is entered into a central online database created by the Secutrial platform. This&#xD;
      platform is provided by the University Hospital of Geneva's Clinical Research Unit. The&#xD;
      database disposes of an audit-trail capacity. Local principal investigators are responsible&#xD;
      for data-cross check and quality management. Source data verification is performed by&#xD;
      investigators on site who address missing data. Regular meetings are held to discuss data&#xD;
      patency.&#xD;
&#xD;
      The platform automatically provides a report on recruitment progress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>5 Years</target_duration>
  <primary_outcome>
    <measure>Functional outcome as assessed by the modified Rankin scale</measure>
    <time_frame>5 years after hemorrhage</time_frame>
    <description>The modified Rankin scale is used to represent the level of disability and is divided into 7 categories (0-6). The scale runs from 0-6, running from perfect health without symptoms to death.&#xD;
0 - No symptoms.&#xD;
- No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
- Moderate disability. Requires some help, but able to walk unassisted.&#xD;
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.&#xD;
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
- Dead.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Intracranial Aneurysm</condition>
  <arm_group>
    <arm_group_label>Aneurysmal Subarachnoid hemorrhage</arm_group_label>
    <description>Patients suffering from a ruptured cerebral aneurysm are included in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational/ no intervention</intervention_name>
    <arm_group_label>Aneurysmal Subarachnoid hemorrhage</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted in Switzerland with a diagnosis of aneurysmal subarachnoid hemorrhage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Patients admitted with a proven diagnosis of aneurysmal subarachnoid hemorrhage.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Patients in whom the source of haemorrhage could not be identified (angiogram-negative&#xD;
        SAH) or SAH with other causes than cerebral aneurysms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karl Schaller, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bawarjan Schatlo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin N Stienen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe Bijlenga, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karl Schaller, MD</last_name>
    <phone>+41223728202</phone>
    <email>karl.schaller@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philippe Bijlenga, MD PhD</last_name>
    <phone>+41792044043</phone>
    <email>philippe.bijlenga@hcuge.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kantonsspital Aarau</name>
      <address>
        <city>Aarau</city>
        <state>Aargau</state>
        <zip>5000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serge Marbacher, MD</last_name>
      <email>serge.marbacher@ksa.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <state>GE</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karl Schaller, MD</last_name>
      <phone>+41223728202</phone>
      <email>karl.schaller@hcuge.ch</email>
    </contact>
    <contact_backup>
      <last_name>Philippe Bijlenga, MD, PhD</last_name>
      <phone>+41223723246</phone>
      <email>philippe.bijlenga@hcuge.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Karl Schaller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin N Stienen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe Bijlenga, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bawarjan Schatlo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <state>Saint Gallen</state>
        <zip>9000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Seule, MD</last_name>
      <email>martin.seule@kssg.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raphael Guzman, MD</last_name>
      <email>raphael.guzman@ukbb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Michel Roethlisberger, MD</last_name>
      <email>coles@bluewin.ch</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University Hospital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Bervini, MD</last_name>
      <email>david.bervini@insel.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roy T Daniel, MD</last_name>
      <email>roy.daniel@chuv.ch</email>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Rodolfo Maduri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Civico</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thoams Robert, MD</last_name>
      <email>Thomas.Robert@eoc.ch</email>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Thomas Robert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Luzerner Kanton Spital</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander F. vonhessling, MD</last_name>
      <email>alexander.vonhessling@luks.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emanuela Keller, MD</last_name>
      <email>emanuela.keller@usz.ch</email>
    </contact>
    <contact_backup>
      <last_name>Jan-Karl Burkhardt, MD</last_name>
      <email>jan-karl.burkhardt@usz.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Zweifel-Zehnder AE, Stienen MN, Chicherio C, Studerus-Germann A, Blasi S, Rossi S, Gutbrod K, Schmid N, Beaud V, Mondadori C, Brugger P, Sacco L, Muri R, Hildebrandt G, Fournier JY, Keller E, Regli L, Fandino J, Mariani L, Raabe A, Daniel RT, Reinert M, Robert T, Schatlo B, Bijlenga P, Schaller K, Monsch AU; Swiss SOS study group. Call for uniform neuropsychological assessment after aneurysmal subarachnoid hemorrhage: Swiss recommendations. Acta Neurochir (Wien). 2015 Sep;157(9):1449-58. doi: 10.1007/s00701-015-2480-y. Epub 2015 Jul 16.</citation>
    <PMID>26179382</PMID>
  </reference>
  <results_reference>
    <citation>Schatlo B, Fung C, Fathi AR, Sailer M, Winkler K, Daniel RT, Bijlenga P, Ahlborn P, Seule M, Zumofen D, Reinert M, Woernle C, Stienen M, Levivier M, Hildebrandt G, Mariani L, Bernays R, Fandino J, Raabe A, Keller E, Schaller K. Introducing a nationwide registry: the Swiss study on aneurysmal subarachnoid haemorrhage (Swiss SOS). Acta Neurochir (Wien). 2012 Dec;154(12):2173-8; discussion 2178. doi: 10.1007/s00701-012-1500-4. Epub 2012 Oct 6.</citation>
    <PMID>23053275</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 23, 2015</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Philippe Bijlenga</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Subarachnoid Hemorrhage</keyword>
  <keyword>Intracranial Aneurysm</keyword>
  <keyword>Ruptured Intracranial Aneurysm</keyword>
  <keyword>Neurosurgery</keyword>
  <keyword>Interventional Neuroradiology</keyword>
  <keyword>Neurointensive Care Medicine</keyword>
  <keyword>Switzerland</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>N/A, observational study</ipd_description>
  </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/NCT03245866
org study id: SwissSOS_0001
nct id: NCT03245866
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This registry was created to assess management parameters of patients treated for aneurysmal
      subarachnoid hemorrhage in Switzerland. All Swiss hospitals with a neurosurgery department,
      an intensive care unit and an interventional neuroradiology team that treat neurovascular
      emergencies participate in the registry. Clinical parameters are entered into a common
      database. This database will provide (1) a nationwide assessment of the current standard of
      care and (2) the outcomes for patients in Switzerland including neuropsychological
      assessments.
Overview:

      The management of aneurysmal subarachnoid hemorrhage (aSAH) in Switzerland has not been
      assessed on a national level to date. The investigators united all comprehensive
      neurovascular care centres in Switzerland to create a registry for aSAH. This registry helps
      collect clinical and management data from different centres and pools it in one common
      database. It may provide referring caregivers and healthcare providers with a critical tool
      to assess the quality of care in a disease which has a high socio-economic burden. Moreover,
      it may serve as a tool to foster scientific collaboration and address a number of remaining
      questions about the management of aSAH in the future. Regarding SAH, data from the federal
      statistics bureau of Switzerland are based strictly on ICD-10 codes provided by hospitals and
      show an estimate of 13 per 100,000 in a population of roughly 8 million
      (http://bfs.admin.ch). These numbers, however, are not referring to aneurismal SAH
      exclusively and thus exceed the numbers which the investigators expect to obtain. The goal is
      to obtain complete recruitment of SAH patients throughout Switzerland, and the goal is
      therefore that assessment of incidence will be performed later on.

      Data management:

      Data is entered into a central online database created by the Secutrial platform. This
      platform is provided by the University Hospital of Geneva's Clinical Research Unit. The
      database disposes of an audit-trail capacity. Local principal investigators are responsible
      for data-cross check and quality management. Source data verification is performed by
      investigators on site who address missing data. Regular meetings are held to discuss data
      patency.

      The platform automatically provides a report on recruitment progress.
observational model: Cohort
time perspective: Prospective
measure: Functional outcome as assessed by the modified Rankin scale
time frame: 5 years after hemorrhage
description: The modified Rankin scale is used to represent the level of disability and is divided into 7 categories (0-6). The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
arm group label: Aneurysmal Subarachnoid hemorrhage
description: Patients suffering from a ruptured cerebral aneurysm are included in the study.
intervention type: Other
intervention name: Observational/ no intervention
arm group label: Aneurysmal Subarachnoid hemorrhage
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Karl Schaller, MD
role: Study Director
affiliation: University Hospital, Geneva
last name: Bawarjan Schatlo, MD
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: Martin N Stienen, MD
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: Philippe Bijlenga, MD PhD
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: Karl Schaller, MD
phone: +41223728202
email: karl.schaller@hcuge.ch
last name: Philippe Bijlenga, MD PhD
phone: +41792044043
email: philippe.bijlenga@hcuge.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
citation: Zweifel-Zehnder AE, Stienen MN, Chicherio C, Studerus-Germann A, Blasi S, Rossi S, Gutbrod K, Schmid N, Beaud V, Mondadori C, Brugger P, Sacco L, Muri R, Hildebrandt G, Fournier JY, Keller E, Regli L, Fandino J, Mariani L, Raabe A, Daniel RT, Reinert M, Robert T, Schatlo B, Bijlenga P, Schaller K, Monsch AU; Swiss SOS study group. Call for uniform neuropsychological assessment after aneurysmal subarachnoid hemorrhage: Swiss recommendations. Acta Neurochir (Wien). 2015 Sep;157(9):1449-58. doi: 10.1007/s00701-015-2480-y. Epub 2015 Jul 16.
PMID: 26179382
citation: Schatlo B, Fung C, Fathi AR, Sailer M, Winkler K, Daniel RT, Bijlenga P, Ahlborn P, Seule M, Zumofen D, Reinert M, Woernle C, Stienen M, Levivier M, Hildebrandt G, Mariani L, Bernays R, Fandino J, Raabe A, Keller E, Schaller K. Introducing a nationwide registry: the Swiss study on aneurysmal subarachnoid haemorrhage (Swiss SOS). Acta Neurochir (Wien). 2012 Dec;154(12):2173-8; discussion 2178. doi: 10.1007/s00701-012-1500-4. Epub 2012 Oct 6.
PMID: 23053275
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Philippe Bijlenga
investigator title: MD PhD
mesh term: Subarachnoid Hemorrhage
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Hemorrhage
sharing ipd: No
ipd description: N/A, observational study