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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01136993
Other study ID # M1010NL0002
Secondary ID
Status Recruiting
Phase N/A
First received June 3, 2010
Last updated June 3, 2010
Start date May 2007
Est. completion date December 2010

Study information

Verified date June 2010
Source Helsinki University Central Hospital
Contact Tiina R Sairanen, MD, PhD
Email tiina.sairanen@hus.fi
Is FDA regulated No
Health authority None due to the nature of the study (Registry), Finland':'
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 109
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Finland Department of neurology, HUCH Helsinki

Sponsors (7)

Lead Sponsor Collaborator
Helsinki University Central Hospital Central Hospital of Lapland Rovaniemi Finland, Kuusankoski Regional Hospital Kuusankoski Finland, Kymenlaakso Central Hospital Kotka Finland, Länsi-Pohja Central Hospital Kemi Finland, South Carelia Central Hospital Lappeenranta Finland, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of thrombolysis treatments per consultations 2 years No
Secondary Safety (sICH) and Efficacy (mRS at 3 months) compared with on-site thrombolysis 2 years Yes
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