Stroke Unit in the Philippines: Is it Effective

Acute Stroke Clinical Trial

Official title:

Stroke Unit in the Philippines: Is it Effective?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000959
• Other study ID #: SU-PH1
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 19, 2016
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Jose R. Reyes Memorial Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Philippine Health Review Ethics Board
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 922
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Locations

Country	Name	City	State
Philippines	Jose R. Reyes Memorial Medical Center	Mano

Sponsors (1)

Lead Sponsor	Collaborator
Jose R. Reyes Memorial Medical Center

Country where clinical trial is conducted

Philippines, 

References & Publications (8)

Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.

Devuyst G, Bogousslavsky J. Clinical trial update: neuroprotection against acute ischaemic stroke. Curr Opin Neurol. 1999 Feb;12(1):73-9. Review. — View 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. Review. — View 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. Review. — View Citation

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.

The Stroke Society of the Philippines (SSP) Handbook of Stroke. 6th edition. 2014, 220-227.

Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate		3 Months	No
Secondary	Functional outcome in modified rankin scale		3 and 6 months	No