Prehospital Prediction of Large Anterior Vessel Occlusion

NCT04442659 | Completed

• 1 other identifier: G18.058
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

For the clinical benefit of intravenous thrombolysis "IVT" or intra-arterial thrombectomy "IAT" time is the most crucial factor. Reducing the time between stroke onset en treatment is therefore a major goal. Since IAT is only suitable for stroke due to large anterior vessel occlusion "LAVO" which is only performed in specialized comprehensive stroke centers "CSC", triage of LAVO-patients in the prehospital phase (i.e. in the ambulance) in order to directly allocate them to such a specialized CSC will save vital time (time=brain!). Several LAVO-prediction scales for clinical triage have been developed but most were tested in- hospital by experienced neurologists. Consequently, there is a great need for validation of these scales in the prehospital setting by Emergency Medical Services "EMS" personnel. Objective: to recalibrate, validate performance and assess feasibility of several existing LAVO-prediction scales in the prehospital phase (i.e. assessment by EMS personnel). Study design: multiregional, multicenter observational cohort study to investigate performance and feasibility of LAVO-prediction scales a. Study population: all patients potentially eligible for IVTIAT according to the protocol used by EMS personnel except for when younger than 18 years.

Conditions

Stroke, Acute

Keywords

large vessel occlusion; Endovascular trombectomy; pre-hospital stroke triage

Outcome Measures

Primary Outcomes (2)

• symptomatic Large Anterior Vessel Occlusion

  TICI score

  on admission

• Feasibility outcome

  reconstruction rate of cuttoff and/or full scale

  "within first hour"

Secondary Outcomes (2)

• final diagnosis

  "Three months"

• Endovascular therpay

  "within first 24 hours of admission"

Interventions

pre hospital triage tool DIAGNOSTIC_TEST

EMS workers fill in an application containing 10-13 vclinical items

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All stroke codes within the ambulance regions of the Emergency medical services Hollands midden or Haaglanden.

You may qualify if:

• Acute stroke code activated by EMS personnel

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Alrijne Hospital: collaborator
• Medical Center Haaglanden: collaborator
• Haga Hospital: collaborator
• Groene Hart Ziekenhuis: collaborator
• Reinier de Graaf Groep: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Links

• Stroke triage app

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

NL (1)