- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03520335
Implementation of Finnish Prehospital Stroke Scale to Emergency Medical Services
Implementation of Finnish Prehospital Stroke Scale (FPSS) to Emergency Medical Services - a Prospective, Multi-centre Study
Study Overview
Status
Conditions
Detailed Description
Finnish Prehospital Stroke Scale, FPSS, was developed for prehospital setting for prediction of large vessel occlusions (LVOs) and stroke in common. It contains four stroke signs used universally in emergency medical services (EMSs) and emergency response centers (ERCs): 1) facial weakness, 2) extremity weakness, 3) speech disturbance, 4) visual disturbance. Additionally, it contains only one item 5) conjugated gaze deviation, while all the items are presented in dichotomized form. In an earlier, retrospective cohort of 856 code stroke patients, the sensitivity of FPSS for LVOs was highest for thrombi of areas with the documented cost effectiveness of endovascular treatment: internal carotid artery (ICA) and M1 segment of middle cerebral artery (72 % and 82 %). The overall specificity of FPSS for the LVOs was 91 %. For its simplicity it is easy to implement in EMS and ERC as a single score predicting both thrombolysis and thrombectomy candidates.
In the present study accuracy of FPSS will be studied prospectively. FPSS is launched 5/18 in EMS in an area with a population of more than a million, containing districts of five central hospitals capable for thrombolysis and one university hospital capable for endovascular treatment. During 2019-20 FPSS will be launched in two ERCs triaging stroke patients in the study area.
The hypotheses that are tested are:
- FPSS is accurate to detect ICA and M1 thrombi in EMS setting
- The use of FPSS shortens door-in-door-out (DIDO) delay patients arriving to central hospitals and redirected to university hospital for thrombectomy.
- The use of FPSS aids to triage LVO-patients straight to a center capable for thrombectomy
- FPSS is accurate in the detection of ICA and M1 thrombi in ERC setting
- The effect of fluent triage of LVO is seen in overall shortened recanalization delay and better outcomes as lower modified Rankin Scores (mRS) in 3 months control compared recanalization delays and 3 month mRS during the pre-implementation period.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Satu-Liisa K Pauniaho, MD, PhD
- Phone Number: +358505386783
- Email: satu-liisa.pauniaho@pshp.fi
Study Contact Backup
- Name: Jyrki P Ollikainen, MD
- Phone Number: +358331166067
- Email: jyrki.ollikainen@pshp.fi
Study Locations
-
-
-
Tampere, Finland
- Recruiting
- Tampere University Hospital
-
Contact:
- Satu-Liisa K Pauniaho, MD, PhD
- Phone Number: +358505386783
- Email: satu-liisa.pauniaho@pshp.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acute ischaemic stroke
- Prehospital susipicion of large vessel occlusion
Exclusion Criteria:
- Stroke mimic
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy
Time Frame: 3 years
|
Accuracy of Finnish Prehospital Stroke Scale used in prehospital settingto detect a large vessel occlusion Finnish Prehospital Stroke Scale (FPSS) includes the following items: Facial droop 0-1, Weakness of one or more extremities 0-1, Difficulty of understand or produce speech, including slurring 0-1, Field cut of visus or blindness 0-1, Partial or fixed gaze or head deviation away from the paretic side 0 or 4. Total points 1-4 predicts non-LVO, ≥ 5 predicts LVO 0-8 (non-LVO= small or medium-sized vessel occlusion; iv-thrombolysis candidate; LVO= large vessel occlusion; endovascular treatment candidate) |
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
90 day survival
Time Frame: 3 years
|
90 day survival
|
3 years
|
90 day modified Rankin score
Time Frame: 3 years
|
90 day modified Rankin score
|
3 years
|
Onset to treatment time
Time Frame: 3 years
|
Onset to treatment time
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R18010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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