NCT02647957

Brief Summary

Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

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

First Submitted

Initial submission to the registry

December 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

December 26, 2015

Last Update Submit

May 10, 2016

Conditions

Stroke, Acute

Keywords

acute ischemic strokequality

Outcome Measures

Primary Outcomes (1)

  • Recovery rate of the Intravenous trombolysis treatment

    Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.

    1 month

Secondary Outcomes (6)

  • Patient satisfaction

    1 month

  • Patient engage

    1 month

  • response capacity

    1 day

  • Treatment adequacy: Intravenous trombolysis treatment

    1 month

  • Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Hospital using Code Stroke

Procedure: Code Stroke

Group B

NO INTERVENTION

Hospital not using Code Stroke

Interventions

Code StrokePROCEDURE

Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.

Group A

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute ischemic stroke in-patients

You may not qualify if:

  • Patients who refuse participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alvarez Sabin J, Molina C, Abilleira S, Montaner J, Garcia F, Alijotas J. ["Stroke code". Shortening the delay in reperfusion treatment of acute ischemic stroke]. Med Clin (Barc). 1999 Oct 23;113(13):481-3. Spanish.

    PMID: 10604170RESULT

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share