Prehospital Prediction of Large Anterior Vessel Occlusion (PHPLAVO)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Diagnostic test: pre hospital triage tool

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

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Leiden, Zuid Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Acute stroke code activated by EMS personnel

Exclusion Criteria:

• Age <18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptomatic Large Anterior Vessel Occlusion	TICI score	on admission
Feasibility outcome	reconstruction rate of cuttoff and/or full scale	"within first hour"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
final diagnosis	diagnosis after discharge and/or after three months.	"Three months"
Endovascular therpay	EVT	"within first 24 hours of admission"

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Medical Center Haaglanden; Groene Hart Ziekenhuis; Reinier de Graaf Groep; Haga Hospital; Alrijne Hospital

Publications and helpful links

Helpful Links

• Stroke triage app

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: large vessel occlusion; Endovascular trombectomy; pre-hospital stroke triage
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: G18.058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No