- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03000959
Stroke Unit in the Philippines: Is it Effective
December 19, 2016 updated by: Jose C. Navarro, Jose R. Reyes Memorial Medical Center
Stroke Unit in the Philippines: Is it Effective?
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
Study Overview
Status
Unknown
Conditions
Detailed Description
This study aims to look into functionality of patient admitted in the stroke unit in the Philippines
Study Type
Observational
Enrollment (Anticipated)
922
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mano, Philippines
- Recruiting
- Jose R. Reyes Memorial Medical Center
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Contact:
- Cyrus Escabillas
- Phone Number: 292 7119491
- Email: cyrusesca@gmail.com
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Sub-Investigator:
- Cyrus Escabillas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all consecutive patients diagnosed with stroke (ischemic and hemorrhagic) starting on June 2016.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality Rate
Time Frame: 3 Months
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3 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Functional outcome in modified rankin scale
Time Frame: 3 and 6 months
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3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jose C Navarro, MD, Jose R. Reyes Memorial Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- 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.
- Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
December 12, 2016
First Submitted That Met QC Criteria
December 19, 2016
First Posted (Estimate)
December 22, 2016
Study Record Updates
Last Update Posted (Estimate)
December 22, 2016
Last Update Submitted That Met QC Criteria
December 19, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-PH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Computerized
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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