Recognition of Thrombectomy CandidateNCT03520335
Implementation of Finnish Prehospital Stroke Scale to Emergency Medical Services
An observational study of Recognition of Thrombectomy Candidate, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The investigators have developed a simple prehospital stroke scale (FPSS), containing 5 dichotomized items to recognize both large and small artery thrombi of the brain. FPSS is implemented to both emergency medical services and later, to emergency response centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recognition of Thrombectomy Candidate
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 24 Apr 2018to 31 Dec 2021
- 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 patients with acute stroke in a population of 1 million
Who may be able to join
- Acute ischaemic stroke
- Prehospital susipicion of large vessel occlusion
Who cannot join
- Stroke mimic
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere
Satu-Liisa K Pauniaho, MD, PhD, +358505386783, satu-liisa.pauniaho@pshp.fi
About this study
Official title: Implementation of Finnish Prehospital Stroke Scale (FPSS) to Emergency Medical Services - a Prospective, Multi-centre Study
The investigators have developed a simple prehospital stroke scale (FPSS), containing 5 dichotomized items to recognize both large and small artery thrombi of the brain. FPSS is implemented to both emergency medical services and later, to emergency response centers. The efficacy of the scale and possible improvement of both the patient flow and treatment results will be evaluated.
Read the 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.
- Conditions
- Recognition of Thrombectomy Candidate
- Keywords
- stroke, conjugated eye deviation, prehospital, stroke scale, large vessel occlusion
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
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)
Measured: 3 years
Secondary outcomes (3)
90 day survival
90 day survival
Measured: 3 years
90 day modified Rankin score
90 day modified Rankin score
Measured: 3 years
Onset to treatment time
Onset to treatment time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start24 Apr 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recognition of Thrombectomy CandidateStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District, Vaasa Central Hospital, Vaasa, Finland, Seinajoki Central Hospital, Satakunta Central Hospital, PaijatHame Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520335
- Sponsor's protocol ID
- R18010
- Status last verified
- Feb 2020
- First submitted
- 25 Apr 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Finnish Prehospital Stroke Scale (FPSS) to Emergency Medical Services - a Prospective, Multi-centre Study
- ClinicalTrials.gov ID
- NCT03520335
- Acronym / sponsor ID
- R18010
- Conditions
- Recognition of Thrombectomy Candidate
- Keywords
- stroke, conjugated eye deviation, prehospital, stroke scale, large vessel occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District, Vaasa Central Hospital, Vaasa, Finland, Seinajoki Central Hospital, Satakunta Central Hospital, PaijatHame Central Hospital
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 May 2018 (actual)
- 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.
The investigators have developed a simple prehospital stroke scale (FPSS), containing 5 dichotomized items to recognize both large and small artery thrombi of the brain. FPSS is implemented to both emergency medical services and later, to emergency response centers. The efficacy of the scale and possible improvement of both the patient flow and treatment results will be evaluated.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with acute stroke in a population of 1 million
Key inclusion criteria (2 listed)
- Acute ischaemic stroke
- Prehospital susipicion of large vessel occlusion
Key exclusion criteria (1 listed)
- Stroke mimic
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
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 secondary outcomes
90 day survival
Time frame: 3 years
90 day modified Rankin score
Time frame: 3 years
Onset to treatment time
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: Undecided
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.
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 Recognition of Thrombectomy Candidate, run by Tampere University 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 2 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 7 Feb 2020. 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 Satu-Liisa K Pauniaho, MD, PhD (+358505386783, satu-liisa.pauniaho@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2020.