NCT03000959

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
922

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

December 12, 2016

Last Update Submit

December 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality Rate

    3 Months

Secondary Outcomes (1)

  • Functional outcome in modified rankin scale

    3 and 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose R. Reyes Memorial Medical Center

Maño, Philippines

RECRUITING

Related Publications (8)

  • 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: 22441195BACKGROUND
  • Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85

    BACKGROUND
  • 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: 21571152BACKGROUND
  • 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: 10097888BACKGROUND
  • Peter Langhorne,Martin Dennis. Stroke Units: An evidence based approach. BMJ Books. 1998

    BACKGROUND
  • 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: 7886733BACKGROUND
  • Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.

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

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jose C Navarro, MD

    Jose R. Reyes Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Emeritus, Department of Neurology, Principal Investigator

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 22, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations