Stroke, AcutePHPLAVONCT04442659
Prehospital Prediction of Large Anterior Vessel Occlusion
An observational study of Stroke, Acute, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- pre hospital triage tool
- How many people
- 2,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2018to 1 Jan 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All stroke codes within the ambulance regions of the Emergency medical services Hollands midden or Haaglanden.
Who may be able to join
- Acute stroke code activated by EMS personnel
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: 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).
Read more
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.
Read the 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
- Conditions
- Stroke, Acute
- Being tested
- pre hospital triage tool
- Keywords
- large vessel occlusion, Endovascular trombectomy, pre-hospital stroke triage
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre hospital triage toolDiagnostic test
EMS workers fill in an application containing 10-13 vclinical items
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic Large Anterior Vessel Occlusion
TICI score
Measured: on admission
Feasibility outcome
reconstruction rate of cuttoff and/or full scale
Measured: "within first hour"
Secondary outcomes (2)
final diagnosis
diagnosis after discharge and/or after three months.
Measured: "Three months"
Endovascular therpay
EVT
Measured: "within first 24 hours of admission"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jul 2018
- Primary completion1 Oct 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alrijne Hospital, Medical Center Haaglanden, Haga Hospital, Groene Hart Ziekenhuis, Reinier de Graaf Groep
- Responsible party
- Principal investigator, NyikaKruyt, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442659
- Sponsor's protocol ID
- G18.058
- Acronym
- PHPLAVO
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Large Anterior Vessel Occlusion: a Prospective Observational Study Comparing Prehospital Prediction Scales
- ClinicalTrials.gov ID
- NCT04442659
- Acronym / sponsor ID
- PHPLAVO / G18.058
- Conditions
- Stroke, Acute
- Keywords
- large vessel occlusion, Endovascular trombectomy, pre-hospital stroke triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Alrijne Hospital, Medical Center Haaglanden, Haga Hospital, Groene Hart Ziekenhuis, Reinier de Graaf Groep
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All stroke codes within the ambulance regions of the Emergency medical services Hollands midden or Haaglanden.
Key inclusion criteria (1 listed)
- Acute stroke code activated by EMS personnel
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre hospital triage toolEMS workers fill in an application containing 10-13 vclinical items | Diagnostic test | – |
Primary outcome
symptomatic Large Anterior Vessel Occlusion
Time frame: on admission
TICI score
Feasibility outcome
Time frame: "within first hour"
reconstruction rate of cuttoff and/or full scale
2 secondary outcomes
final diagnosis
Time frame: "Three months"
Endovascular therpay
Time frame: "within first 24 hours of admission"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Stroke triage appLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic Large Anterior Vessel Occlusion (time frame: on admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.