Finnish Telestroke Pilot 2007-2009 | NCT01136993

Studies
Finnish Telestroke Pilot 2007-2009

NCT01136993

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

Jun 4, 2010Estimated

Enrollment

109Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

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

Jun 2010

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

May 2007

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 3, 2010

First Submission Date that Met QC Criteria

Jun 3, 2010

First Posted Date

Jun 4, 2010Estimated

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

Jun 3, 2010

Last Update Posted Date

Jun 4, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
Kuusankoski Regional Hospital Kuusankoski Finland	UNKNOWN
Kymenlaakso Central Hospital Kotka Finland	OTHER
Tampere University 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

Objective is to describe two years experience from The Finnish Telestroke piloting between Helsinki University Central Hospital (HUCH), Department of Neurology, The Hub, and five hospitals, the spokes. The participating hospitals are from Rovaniemi (Lapland), Kemi (North-West of Finland), Lappeenranta, Kuusankoski and Kotka from South-East of Finland. All the participating hospitals have a stroke unit and the thrombolysis treatment and the follow up of the patients are carried in the treating hospital. The aim of the pilot is to provide these hospitals expertise in thrombolysis treatment during off-hours through teleconsultations.

The teleconsultations were begun between the participating hospitals 05/2007 after about 1 years preparation period. During the preparation period the staff from participating hospitals were trained with simulation training and lectures held by the local staff and the faculty of the Helsinki University hospital.

Telestroke consultation: During two way interactive audio-visual consultation the thrombolysis decision is based on: 1) the consultant going through a check up list of indications and no contraindications to the treatment together with the treating physician and 2) Clinical assessment of NIHSS by the treating physician under guidance of the consultant through the two way video system besides 3) Evaluation of the head CT scan.

The data registered is based on documents made at HUCH and the follow up data provided by the chief neurologist of the other hospitals. 109 teleconsultations have been documented over 2 years period. A unique feature of the Finnish pilot is the high percentage of consultations leading to thrombolysis treatment. Another special feature is that the consultant does the teleconsultation work besides other on call duties.

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

No data available

No data is available for this block.

Enrollment

109Estimated

Label	Type	Description	Intervention Names
All bi-directional telestroke consultations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of thrombolysis treatments per consultations		2 years

Secondary Outcomes

Measure	Description	Time Frame
Safety (sICH) and Efficacy (mRS at 3 months) compared with on-site thrombolysis		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All stroke patients inside 4.5 hours from the symptom onset considered as thrombolysis candidates by the treating physician of the spoke. In suspected basilar artery thrombosis up to 48 h from symptom onset.

Exclusion Criteria:

Symptom onset > 4.5 h

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

All teleconsultations on stroke thrombolysis decision between the Hub (HUCH) and the 5 Spokes during 2 years time period.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tiina R Sairanen, MD, PhD	Contact			tiina.sairanen@hus.fi
Turgut Tatlisumak, MD, PhD	Contact			turgut.tatlisumak@hus.fi

Overall Officials

Name	Affiliation	Role
Tiina Sairanen, MD, PhD	Department of Neurology, HUCH, Helsinki, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of neurology, HUCH	Recruiting	Helsinki			Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19546538	Background	Tatlisumak T, Soinila S, Kaste M. Telestroke networking offers multiple benefits beyond thrombolysis. Cerebrovasc Dis. 2009;27 Suppl 4:21-7. doi: 10.1159/000213055. Epub 2009 Jun 18.

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