StrokeNCT01136993
Finnish Telestroke Pilot 2007-2009
An observational study of Stroke, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- How many people
- 109 participants
- Where
- 1 siteFinland
- Study dates
- May 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All teleconsultations on stroke thrombolysis decision between the Hub (HUCH) and the 5 Spokes during 2 years time period.
Who may be able to join
- 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.
Who cannot join
- Symptom onset > 4.5 h
Trial locations and contacts
1 site in 1 country.
Tiina R Sairanen, MD, PhD contact
Turgut Tatlisumak, MD, PhD contact
Finland1 site, 1 recruiting
- Recruiting
Department of neurology, HUCH
Helsinki
Tiina Sairanen, MD, PhD
About this study
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.
Read more
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.
- Conditions
- Stroke
- Keywords
- Stroke, Thrombolysis, Telestroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All bi-directional telestroke consultations | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of thrombolysis treatments per consultations
Measured: 2 years
Secondary outcomes (1)
Safety (sICH) and Efficacy (mRS at 3 months) compared with on-site thrombolysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startMay 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuusankoski Regional Hospital Kuusankoski Finland, Kymenlaakso Central Hospital Kotka Finland, Tampere University Hospital, Lapland Central Hospital, South Carelia Central Hospital, Länsi-Pohja Central Hospital Kemi Finland
- Investigators
- Tiina Sairanen, MD, PhD, Principal investigator, Department of Neurology, HUCH, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136993
- Sponsor's protocol ID
- M1010NL0002
- Status last verified
- Jun 2010
- First submitted
- 3 Jun 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19546538
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Telestroke Pilot 2007-2009
- ClinicalTrials.gov ID
- NCT01136993
- Acronym / sponsor ID
- M1010NL0002
- Conditions
- Stroke
- Keywords
- Stroke, Thrombolysis, Telestroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Kuusankoski Regional Hospital Kuusankoski Finland, Kymenlaakso Central Hospital Kotka Finland, Tampere University Hospital, Lapland Central Hospital, South Carelia Central Hospital, Länsi-Pohja Central Hospital Kemi Finland
- Study start
- May 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All bi-directional telestroke consultations | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All teleconsultations on stroke thrombolysis decision between the Hub (HUCH) and the 5 Spokes during 2 years time period.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Symptom onset > 4.5 h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of thrombolysis treatments per consultations
Time frame: 2 years
1 secondary outcome
Safety (sICH) and Efficacy (mRS at 3 months) compared with on-site thrombolysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Background: PubMed 19546538Tatlisumak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina R Sairanen, MD, PhD contact
Turgut Tatlisumak, MD, PhD contact
Tiina Sairanen, MD, PhD principal investigator
Department of Neurology, HUCH, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiina R Sairanen, MD, PhD (tiina.sairanen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of thrombolysis treatments per consultations (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.