Epidemiology and Cost-effectiveness of Out-Of-Hospital Ca... | NCT01295424

Studies
Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland

NCT01295424

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Feb 2, 2015Estimated

Enrollment

2,600Actual

Phase

Not provided

Conditions

Cardiac Arrest

Interventions

No intervention

Countries

Finland

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

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 11, 2011

First Posted Date

Feb 14, 2011Estimated

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

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

Name	Class
Helsinki University Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac arrest primary survivors admitted to all Finnish ICUs.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single group study			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Observational study, no interventions	Single group study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alive at hospital discharge (time frame: Hospital discharge day)	alive at hospital discharge	12 hours

Secondary Outcomes

Measure	Description	Time Frame
CPC (time frame: 1 year after cardiac arrest)	Neurologic outcome (Cerebral Performance Category) at one year after out of hospital cardiac arrest.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Out-of-hospital cardiac arrest patients

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Out-of-hospital cardiac arrest patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tom Silfvast, MD, PhD	Helsinki University Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio		70211	Finland

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided