NCT04404504

Brief Summary

The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

May 18, 2020

Last Update Submit

August 29, 2022

Conditions

Acute Stroke

Keywords

Prehospital Triage

Outcome Measures

Primary Outcomes (1)

  • Presence of large vessel occlusion

    Acute stroke due to large vessel occlusion as measured by computed tomography angiography (CT-A)

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients with suspected acute stroke that are transferred by the Essen emergency service to the university hospital Essen shall be recruited

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

  • Frank B, Lembeck T, Toppe N, Brune B, Bozkurt B, Deuschl C, Nogueira RG, Dudda M, Risse J, Kill C, Forsting M, Kleinschnitz C, Kohrmann M. FAST-ED scale smartphone app-based prediction of large vessel occlusion in suspected stroke by emergency medical service. Ther Adv Neurol Disord. 2021 Nov 14;14:17562864211054962. doi: 10.1177/17562864211054962. eCollection 2021.

    PMID: 34804205RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Köhrmann, Prof. Dr.

    University Hospital, Essen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 27, 2020

Study Start

March 20, 2019

Primary Completion

August 1, 2020

Study Completion

December 30, 2020

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

DE(1)