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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06332989
Other study ID # N22.129
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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