Ischemic StrokeNCT04834284
HEMS for Mechanical Thrombectomy
An observational study of Ischemic Stroke, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. Pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2020to 31 Dec 2023
- How long will I take part?
- 90 Days
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Either verified large vessel occlusion with computed tomography angiography in Seinäjoki central hospital or positive prehospital stroke severity scale for large vessel occlusion (Finnish Prehospital Stroke Scale: FPSS) and eligibility for mechanical thrombectomy
Who may be able to join
- all adult patients transferred for mechanical thrombectomy from the South Ostrobothnia Hospital District to the Tampere University Hospital
Who cannot join
- The neurologist on call at the Tampere University hospital deems the patient unable to benefit from mechanical thrombectomy
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University hospital
Tampere, 33521
Sanna Hoppu, MD, PhD, 3583311611, sanna.hoppu@pshp.fi
Piritta Setälä, MD, PhD
About this study
Official title: Decreasing Prehospital Delay to Mechanical Thrombectomy Using a Helicopter Emergency Medical Services Unit
Elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. Pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. Mechanical thrombectomy can be done only in comprehensive stroke centres. There are 5 comprehensive stroke centres in Finland which causes regional inequality when it comes to reaching mechanical thrombectomy in a reasonable time limit.
The aims of the study is to measure the effect of dispatching a helicopter emergency medical services unit on the treatment delays of a stroke patient with large vessel occlusion. The HEMS unit is dispatched to both: getting patient directly to the comprehensive stroke centre as well as to interfacility tranfers.
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Helicopter Emergency Medical Services (HEMS) | Patients transported to the comprehensive stroke centre at least in some part by a HEMS unit | |
| Ground Emergency Medical Services (GEMS) | Patients transported to the comprehensive stroke centre solely by an ambulance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of transport times from the onset of ambulance transport to Tampere university hospital until the recording of CT Scout image
minutes
Measured: from onset of symptoms up to 24 hours
Secondary outcomes (4)
The difference of onset to revascularisation time between the groups from the onset of symptoms (last known well) until save time of "post revascularization" image
minutes
Measured: from onset of symptoms up to 24 hours
The time difference from the onset of symptoms (last known well) until the save time of "post revascularization" image
minutes
Measured: from onset of symptoms up to 24 hours
90 days modified Rankin scale outcome
mRS 0-6
Measured: telephone interview 90 days after mechanical thrombectomy
Availability of the ambulance to the next emergency medical services mission in its own region. Time to next ems mission
hours
Measured: from the beginning of ambulance transport up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Hoppu, Tampere University Hospital
- Investigators
- Sanna Hoppu, MD, PhD, Study director, Centre of Emergency Medical Services, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834284
- Sponsor's protocol ID
- R20082
- Status last verified
- Jan 2023
- First submitted
- 31 Mar 2021
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Prehospital Delay to Mechanical Thrombectomy Using a Helicopter Emergency Medical Services Unit
- ClinicalTrials.gov ID
- NCT04834284
- Acronym / sponsor ID
- R20082
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Apr 2021 (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.
Elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. Pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. Mechanical thrombectomy can be done only in comprehensive stroke centres. There are 5 comprehensive stroke centres in Finland which causes regional inequality when it comes to reaching mechanical thrombectomy in a reasonable time limit.
The aims of the study is to measure the effect of dispatching a helicopter emergency medical services unit on the treatment delays of a stroke patient with large vessel occlusion. The HEMS unit is dispatched to both: getting patient directly to the comprehensive stroke centre as well as to interfacility tranfers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helicopter Emergency Medical Services (HEMS) | – | –Patients transported to the comprehensive stroke centre at least in some part by a HEMS unit |
| Ground Emergency Medical Services (GEMS) | – | –Patients transported to the comprehensive stroke centre solely by an ambulance |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Either verified large vessel occlusion with computed tomography angiography in Seinäjoki central hospital or positive prehospital stroke severity scale for large vessel occlusion (Finnish Prehospital Stroke Scale: FPSS) and eligibility for mechanical thrombectomy
Key inclusion criteria (1 listed)
- all adult patients transferred for mechanical thrombectomy from the South Ostrobothnia Hospital District to the Tampere University Hospital
Key exclusion criteria (1 listed)
- The neurologist on call at the Tampere University hospital deems the patient unable to benefit from mechanical thrombectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference of transport times from the onset of ambulance transport to Tampere university hospital until the recording of CT Scout image
Time frame: from onset of symptoms up to 24 hours
minutes
4 secondary outcomes
The difference of onset to revascularisation time between the groups from the onset of symptoms (last known well) until save time of "post revascularization" image
Time frame: from onset of symptoms up to 24 hours
The time difference from the onset of symptoms (last known well) until the save time of "post revascularization" image
Time frame: from onset of symptoms up to 24 hours
90 days modified Rankin scale outcome
Time frame: telephone interview 90 days after mechanical thrombectomy
Availability of the ambulance to the next emergency medical services mission in its own region. Time to next ems mission
Time frame: from the beginning of ambulance transport up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
Sanna Hoppu, MD, PhD study director
Centre of Emergency Medical Services, Tampere University Hospital
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 Ischemic Stroke, run by Tampere University Hospital at 1 site in Finland.
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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauli Vuorinen, MD (+358+3+311611, pauli.e.vuorinen@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of transport times from the onset of ambulance transport to Tampere university hospital until the recording of CT Scout image (time frame: from onset of symptoms up to 24 hours). 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 18 Jan 2023.