Stroke Triage Optimization by Ambulance Paramedics in the... | NCT06332989

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

NCT06332989

Sponsor

Leiden University Medical Center

Status

Recruiting

Last Update Posted

Mar 27, 2024Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Stroke, Acute
Pre-hospital Triage
Stroke Treatment
Stroke Code

Interventions

stroke-APP

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Feb 1, 2027Estimated

Completion Date

Feb 1, 2027Estimated

First Submitted Date

Mar 20, 2024

First Submission Date that Met QC Criteria

Mar 20, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2024

Last Update Posted Date

Mar 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

NyikaKruyt, M, PhD, Leiden University Medical CenterPrincipal Investigator

Lead Sponsor

Leiden University Medical CenterOTHER

Collaborators

Name	Class
Alrijne Ziekenhuis Leiderdorp	NETWORK
Groene Hart Ziekenhuis	OTHER
Medical Center Haaglanden	OTHER
HagaZiekenhuis

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stroke-APP	Other	Ambulane paramedics will use an online application to fill in several observations on scen

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients for whom a stroke code is activated

Exclusion Criteria:

< 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients for whom a stroke code was activated.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University medical center	Recruiting	Leiden			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided