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Prehospital Prediction of Large Anterior Vessel Occlusion

Prediction of Large Anterior Vessel Occlusion: a Prospective Observational Study Comparing Prehospital Prediction Scales

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04442659
Acronym
PHPLAVO
Enrollment
2000
Registered
2020-06-22
Start date
2018-07-01
Completion date
2020-01-01
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

Keywords

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

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.

Detailed description

The study will be conducted in two EMS regions: Hollands Midden and Haaglanden. In addition, all hospitals in these regions that treat over 30 patients per year with IVT will participate, including at least 1 CSC with IAT-availability per region. These hospitals are: Leiden University Medical Center LUMC; Alrijne hospital (location Leiderdorp); Haaglanden Medical Center (HMC+); Haga hospital; LangeLand hospital (LLZ) and Reinier de Graaf hospital (RdGG). The observational design is pragmatic and reflects standard practice for acute stroke care. inclusion: All patients with suspected stroke potentially eligible for IVT/IAT as estimated by the on-site EMS nurse. A web based application is used that merely structures observations that are currently noted on transport charts. EMS personnel will have access to the web-based application via the iPad/tablet/smartphone/computer on which the EMS transport chart is already filled out as part of standard care. Or via their patient record as used in the ambulance. The application will consist of the following items: * EMS transport number * time of symptom onset * probability of LAVO estimated by EMS nurse * 9-12 questions to structure clinical observations made by the EMS nurse. The application will be straightforward and designed in close co-operation with EMS personnel. With the items acquired all prediction scales can be reconstructed. Data of the application will be retrieved retrospectively and coupled with retrospectively collected data from the participating hospitals by a trusted third party

Interventions

DIAGNOSTIC_TESTpre hospital triage tool

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

Sponsors

Alrijne Hospital
CollaboratorOTHER
Medical Center Haaglanden
CollaboratorOTHER
Haga Hospital
CollaboratorOTHER
Groene Hart Ziekenhuis
CollaboratorOTHER
Reinier de Graaf Groep
CollaboratorOTHER
Leiden University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Acute stroke code activated by EMS personnel

Exclusion criteria

* Age \<18 years

Design outcomes

Primary

MeasureTime frameDescription
symptomatic Large Anterior Vessel Occlusionon admissionTICI score
Feasibility outcomewithin first hourreconstruction rate of cuttoff and/or full scale

Secondary

MeasureTime frameDescription
final diagnosisThree monthsdiagnosis after discharge and/or after three months.
Endovascular therpaywithin first 24 hours of admissionEVT

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026