Stroke Unit in the Philippines: Is it Effective | NCT03000959

Studies
Stroke Unit in the Philippines: Is it Effective

NCT03000959

Sponsor

Jose R. Reyes Memorial Medical Center

Status

Unknown status

Last Update Posted

Dec 22, 2016Estimated

Enrollment

922Estimated

Phase

Not provided

Conditions

Acute Stroke

Interventions

Not provided

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Dec 19, 2016

First Posted Date

Dec 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose C. Navarro, Chairman Emeritus, Department of Neurology, Principal Investigator, Jose R. Reyes Memorial Medical CenterPrincipal Investigator

Lead Sponsor

Jose R. Reyes Memorial Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

922Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality Rate		3 Months

Secondary Outcomes

Measure	Description	Time Frame
Functional outcome in modified rankin scale		3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all consecutive patients diagnosed with stroke (ischemic and hemorrhagic) starting on June 2016.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose C Navarro, MD	Jose R. Reyes Memorial Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jose R. Reyes Memorial Medical Center	Recruiting	Maño			Philippines

References Module

Citations

PubMed Identifier	Type	Citation
22441195	Background	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.
	Background	Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85
21571152

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases