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NCT Number: NCT04442659

Prehospital Prediction of Large Anterior Vessel Occlusion

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute stroke code activated by EMS personnel

Exclusion criteria

  • Age <18 years

Treatment and study plan

pre hospital triage tool

Diagnostic Test

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

Primary outcomes

  1. symptomatic Large Anterior Vessel Occlusion

    Time frame: on admission

    TICI score

  2. Feasibility outcome

    Time frame: "within first hour"

    reconstruction rate of cuttoff and/or full scale

Secondary outcomes

  1. final diagnosis

    Time frame: "Three months"

    diagnosis after discharge and/or after three months.

  2. Endovascular therpay

    Time frame: "within first 24 hours of admission"

    EVT

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Alrijne Hospital
  • Groene Hart Ziekenhuis
  • Haga Hospital
  • Medical Center Haaglanden
  • Reinier de Graaf Groep

Registry information

Official study title

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

Acronym: PHPLAVO

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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