ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementation of Finnish Prehospital Stroke Scale to Emergency Medical Services

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03520335
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
Central Finland Hospital District
Vaasa Central Hospital, Vaasa, Finland
Seinajoki Central Hospital
Satakunta Central Hospital
PaijatHame Central Hospital
Information provided by (Responsible Party):
Tampere University Hospital

Brief 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. The efficacy of the scale and possible improvement of both the patient flow and treatment results will be evaluated.

Condition or disease
Recognition of Thrombectomy Candidate

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:

  1. FPSS is accurate to detect ICA and M1 thrombi in EMS setting
  2. The use of FPSS shortens door-in-door-out (DIDO) delay patients arriving to central hospitals and redirected to university hospital for thrombectomy.
  3. The use of FPSS aids to triage LVO-patients straight to a center capable for thrombectomy
  4. FPSS is accurate in the detection of ICA and M1 thrombi in ERC setting
  5. 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 : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Implementation of Finnish Prehospital Stroke Scale (FPSS) to Emergency Medical Services - a Prospective, Multi-centre Study
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 90 day survival [ Time Frame: 3 years ]
    90 day survival

  2. 90 day modified Rankin score [ Time Frame: 3 years ]
    90 day modified Rankin score

  3. Onset to treatment time [ Time Frame: 3 years ]
    Onset to treatment time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with acute stroke in a population of 1 million
Criteria

Inclusion Criteria:

  • Acute ischaemic stroke
  • Prehospital susipicion of large vessel occlusion

Exclusion Criteria:

- Stroke mimic


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520335


Contacts
Contact: Satu-Liisa K Pauniaho, MD, PhD +358505386783 satu-liisa.pauniaho@pshp.fi
Contact: Jyrki P Ollikainen, MD +358331166067 jyrki.ollikainen@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Satu-Liisa K Pauniaho, MD, PhD    +358505386783    satu-liisa.pauniaho@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Central Finland Hospital District
Vaasa Central Hospital, Vaasa, Finland
Seinajoki Central Hospital
Satakunta Central Hospital
PaijatHame Central Hospital

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03520335     History of Changes
Other Study ID Numbers: R18010
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tampere University Hospital:
stroke
conjugated eye deviation
prehospital
stroke scale
large vessel occlusion

Additional relevant MeSH terms:
Stroke
Emergencies
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes