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Stroke Unit in the Philippines: Is it Effective

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ClinicalTrials.gov Identifier: NCT03000959
Recruitment Status : Unknown
Verified December 2016 by Jose C. Navarro, Jose R. Reyes Memorial Medical Center.
Recruitment status was:  Recruiting
First Posted : December 22, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jose C. Navarro, Jose R. Reyes Memorial Medical Center

Brief Summary:
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

Condition or disease
Acute Stroke

Detailed Description:
This study aims to look into functionality of patient admitted in the stroke unit in the Philippines

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Study Type : Observational
Estimated Enrollment : 922 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stroke Unit in the Philippines: Is it Effective?
Study Start Date : April 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017



Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Functional outcome in modified rankin scale [ Time Frame: 3 and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all consecutive patients diagnosed with stroke (ischemic and hemorrhagic) starting on June 2016.
Criteria

Inclusion Criteria:

  • All consecutive patients admitted in participating SUs starting June 2016 during acute stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by CT-Scan or MRI, will be included

Exclusion Criteria:

  • Patient who had previous of stroke and secondary cause of intracerebral hemorrhage such as trauma, arteriovenous malformation and aneurysm are not included in the study. Those who transferred from other institutions will be excluded. And also, patients who are below 18 years old are excluded in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000959


Locations
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Philippines
Jose R. Reyes Memorial Medical Center Recruiting
Mano, Philippines
Contact: Cyrus Escabillas    7119491 ext 292    cyrusesca@gmail.com   
Sub-Investigator: Cyrus Escabillas         
Sponsors and Collaborators
Jose R. Reyes Memorial Medical Center
Investigators
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Principal Investigator: Jose C Navarro, MD Jose R. Reyes Memorial Medical Center

Publications:
Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85
Peter Langhorne,Martin Dennis. Stroke Units: An evidence based approach. BMJ Books. 1998
Stroke Unit Trialists' Collaboration. A systematic review of specialist multi‐disciplinary (stroke unit) care for stroke inpatients. In: Warlow C, van Gijn J, Sandercock P, eds. Stroke Module of Cochrane Database of Systematic Reviews. London, BMJ Publishing Group, 1995.
Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.
The Stroke Society of the Philippines (SSP) Handbook of Stroke. 6th edition. 2014, 220-227.

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Responsible Party: Jose C. Navarro, Chairman Emeritus, Department of Neurology, Principal Investigator, Jose R. Reyes Memorial Medical Center
ClinicalTrials.gov Identifier: NCT03000959     History of Changes
Other Study ID Numbers: SU-PH1
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Computerized

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases