NCT03520335

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

April 25, 2018

Last Update Submit

February 6, 2020

Conditions

Keywords

strokeconjugated eye deviationprehospitalstroke scalelarge vessel occlusion

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 years

Secondary Outcomes (3)

  • 90 day survival

    3 years

  • 90 day modified Rankin score

    3 years

  • Onset to treatment time

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with acute stroke in a population of 1 million

You may qualify if:

  • Acute ischaemic stroke
  • Prehospital susipicion of large vessel occlusion

You may not qualify if:

  • \- Stroke mimic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Satu-Liisa K Pauniaho, MD, PhD

CONTACT

Jyrki P Ollikainen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 9, 2018

Study Start

April 24, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations