Clinical trial NCT04442659: Prehospital Prediction of Large Anterior Vessel Occlusion
Official title: Prediction of Large Anterior Vessel Occlusion: a Prospective Observational Study Comparing Prehospital Prediction Scales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Keywords: large vessel occlusion
Endovascular trombectomy
pre-hospital stroke triage
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Alrijne Hospital
name: Medical Center Haaglanden
name: Haga Hospital
name: Groene Hart Ziekenhuis
name: Reinier de Graaf Groep
First posted: 2020-06-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All stroke codes within the ambulance regions of the Emergency medical services Hollands midden or Haaglanden.

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

Eligibility criteria: Inclusion Criteria:

* Acute stroke code activated by EMS personnel

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: symptomatic Large Anterior Vessel Occlusion
timeFrame: on admission
measure: Feasibility outcome
timeFrame: "within first hour"
Secondary outcomes:
measure: final diagnosis
timeFrame: "Three months"
measure: Endovascular therpay
timeFrame: "within first 24 hours of admission"
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
Study officials:
References: