<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/NCT03000959</url>
  </required_header>
  <id_info>
    <org_study_id>SU-PH1</org_study_id>
    <nct_id>NCT03000959</nct_id>
  </id_info>
  <brief_title>Stroke Unit in the Philippines: Is it Effective</brief_title>
  <official_title>Stroke Unit in the Philippines: Is it Effective?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jose R. Reyes Memorial Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jose R. Reyes Memorial Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing&#xD;
      the functional outcome between those patient admitted in the general neurology wards and&#xD;
      stroke units using modified Rankin Scale&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to look into functionality of patient admitted in the stroke unit in the&#xD;
      Philippines&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality Rate</measure>
    <time_frame>3 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional outcome in modified rankin scale</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">922</enrollment>
  <condition>Acute Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        all consecutive patients diagnosed with stroke (ischemic and hemorrhagic) starting on June&#xD;
        2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive patients admitted in participating SUs starting June 2016 during acute&#xD;
             stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by&#xD;
             CT-Scan or MRI, will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who had previous of stroke and secondary cause of intracerebral hemorrhage&#xD;
             such as trauma, arteriovenous malformation and aneurysm are not included in the study.&#xD;
             Those who transferred from other institutions will be excluded. And also, patients who&#xD;
             are below 18 years old are excluded in the study&#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>Jose C Navarro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jose R. Reyes Memorial Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jose R. Reyes Memorial Medical Center</name>
      <address>
        <city>Mano</city>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyrus Escabillas</last_name>
      <phone>7119491</phone>
      <phone_ext>292</phone_ext>
      <email>cyrusesca@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Cyrus Escabillas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <reference>
    <citation>Langhorne P, de Villiers L, Pandian JD. Applicability of stroke-unit care to low-income and middle-income countries. Lancet Neurol. 2012 Apr;11(4):341-8. doi: 10.1016/S1474-4422(12)70024-8. Epub 2012 Mar 19.</citation>
    <PMID>22441195</PMID>
  </reference>
  <reference>
    <citation>Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85</citation>
  </reference>
  <reference>
    <citation>Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.</citation>
    <PMID>21571152</PMID>
  </reference>
  <reference>
    <citation>Devuyst G, Bogousslavsky J. Clinical trial update: neuroprotection against acute ischaemic stroke. Curr Opin Neurol. 1999 Feb;12(1):73-9. doi: 10.1097/00019052-199902000-00012.</citation>
    <PMID>10097888</PMID>
  </reference>
  <reference>
    <citation>Peter Langhorne,Martin Dennis. Stroke Units: An evidence based approach. BMJ Books. 1998</citation>
  </reference>
  <reference>
    <citation>Counsell C, Warlow C, Sandercock P, Fraser H, van Gijn J. The Cochrane Collaboration Stroke Review Group. Meeting the need for systematic reviews in stroke care. Stroke. 1995 Mar;26(3):498-502.</citation>
    <PMID>7886733</PMID>
  </reference>
  <reference>
    <citation>Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.</citation>
  </reference>
  <reference>
    <citation>The Stroke Society of the Philippines (SSP) Handbook of Stroke. 6th edition. 2014, 220-227.</citation>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jose R. Reyes Memorial Medical Center</investigator_affiliation>
    <investigator_full_name>Jose C. Navarro</investigator_full_name>
    <investigator_title>Chairman Emeritus, Department of Neurology, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Computerized</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/NCT03000959
org study id: SU-PH1
nct id: NCT03000959
lead sponsor: 
has dmc: Yes
This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing
      the functional outcome between those patient admitted in the general neurology wards and
      stroke units using modified Rankin Scale
This study aims to look into functionality of patient admitted in the stroke unit in the
      Philippines
observational model: Cohort
time perspective: Prospective
measure: Mortality Rate
time frame: 3 Months
measure: Functional outcome in modified rankin scale
time frame: 3 and 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose C Navarro, MD
role: Principal Investigator
affiliation: Jose R. Reyes Memorial Medical Center
facility: 
status: Recruiting
contact: 
investigator: 
country: Philippines
citation: Langhorne P, de Villiers L, Pandian JD. Applicability of stroke-unit care to low-income and middle-income countries. Lancet Neurol. 2012 Apr;11(4):341-8. doi: 10.1016/S1474-4422(12)70024-8. Epub 2012 Mar 19.
PMID: 22441195
citation: Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85
citation: Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PMID: 21571152
citation: Devuyst G, Bogousslavsky J. Clinical trial update: neuroprotection against acute ischaemic stroke. Curr Opin Neurol. 1999 Feb;12(1):73-9. doi: 10.1097/00019052-199902000-00012.
PMID: 10097888
citation: Peter Langhorne,Martin Dennis. Stroke Units: An evidence based approach. BMJ Books. 1998
citation: Counsell C, Warlow C, Sandercock P, Fraser H, van Gijn J. The Cochrane Collaboration Stroke Review Group. Meeting the need for systematic reviews in stroke care. Stroke. 1995 Mar;26(3):498-502.
PMID: 7886733
citation: Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.
citation: The Stroke Society of the Philippines (SSP) Handbook of Stroke. 6th edition. 2014, 220-227.
responsible party type: Principal Investigator
investigator affiliation: Jose R. Reyes Memorial Medical Center
investigator full name: Jose C. Navarro
investigator title: Chairman Emeritus, Department of Neurology, Principal Investigator
mesh term: Stroke
sharing ipd: Undecided
ipd description: Computerized