Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting

Stroke, Acute Clinical Trial

— STROKE-APP  

Official title:

Comparison of Prehospital Stroke Screening Scales in the Ambulance Setting; a Multiregional, Multicenter Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332989
• Other study ID #: N22.129
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics

Description:

this is a multicenter multiregional cohort study including about 3000 stroke code patients. In all patients an application will be filled out before hospital arrival including items that enable us to reconstruct all previously published stroke scales.

Data from the application will be related to in hospital data of the same patient. In order to do this we will use a trusted third party for data coupling.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients for whom a stroke code is activated

Exclusion Criteria:

< 18 years

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• stroke-APP
Ambulane paramedics will use an online application to fill in several observations on scen

Locations

Country	Name	City	State
Netherlands	Leiden University medical center	Leiden

Sponsors (7)

Lead Sponsor	Collaborator
Leiden University Medical Center	Alrijne Ziekenhuis Leiderdorp, Groene Hart Ziekenhuis, HagaZiekenhuis, Medical Center Haaglanden, Regionale Ambulance Voorziening Hollands Midden, Reinier de Graaf Groep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	final diagnosis	Diangosis by treating physician	discharge or after 3 months
Primary	treated with reperfusion therapy	treatment with IV thrombolysis; endovascular therapy or surgery	first 24 hours after admission
Primary	additional investigations	CT scans performed	on admission