Stroke, AcuteAMSUNCT05330715
Mobile Stroke Unit for Pre-hospital Emergency Care
A study testing Management in people with Stroke, Acute and Emergencies, run by Daniel Phillips at 1 site in United Kingdom.
Trial summary
Emergency department overcrowding is a major challenge in medicine, leading to a delay in diagnosis and treatment for the patient due to long waiting times. This is very relevant for diseases like acute stroke and other emergencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Emergencies
- What is being tested?
- Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 836 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2021to 31 Mar 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute emergency patients 18 years or older, who are identified via the national emergency telephone number 999 or 111with suspected severe medical emergency condition, which is categorised as: breathing problem, seizure, falls with head trauma, headache, sick person with suspected infection, stroke, unconsciousness
- calls Monday to Friday 9am to 5 pm
- written informed consent
Who cannot join
- terminally ill patients
- pregnant patients
- patients in cardiac arrest
- patients in custody of Her Majesty's prison service
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East of England Ambulance Service NHS Trust
Melbourn
Daniel Phillips, daniel.phillips@eastamb.nhs.uk
About this study
Official title: Advanced Mobile Stroke Unit for Pre-hospital Emergency Management
Emergency department overcrowding is a major challenge in medicine, leading to a delay in diagnosis and treatment for the patient due to long waiting times. This is very relevant for diseases like acute stroke and other emergencies. The Advanced Mobile Stroke Unit is an ambulance equipped with additional devices to diagnose and treat patients at the emergency site. Patients with less severe conditions can be diagnosed and safely left at home. The objectives of this project are to investigate whether the Advanced Mobile Stroke Unit compared to a normal ambulance enables more accurate triage of patients (treatment at home vs hospital vs specialist vs A\&E). The Advanced Mobile Stroke Unit ambulance will be used in a random order of weeks and this will be compared to weeks with normal ambulances. The study will be carried out by the East of England Ambulance Service NHS Trust in collaboration with the East Suffolk and North Essex NHS Foundation Trust in the East of England. The project is a collaboration with Saarland University, Germany,
- Conditions
- Stroke, Acute, Emergencies
- Being tested
- Management
- Medical subject headings
- Stroke, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManagementOther
Comparison if different strategies to manage acute emergencies in the pre-hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Mobile Stroke Unit | Other | Prehospital treatment of patients with an advanced Mobile Stroke Unit. The advanced Mobile Stroke Unit is an ambulance equipped with a computed tomography scanner, and additional diagnostic devices, such as point-of-care-laboratory and telemedicine to enable the team to diagnose and initiated specialised treatment of emergency patients at the emergency site. Receives: Other: Management |
| Conventional ambulance | Other | Prehospital emergency care with conventional ambulances. Receives: Other: Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring hospital attendance within 4h of acute emergency situation
Patient attendance at hospital related to the emergency call (within 4hours) will be assessed
Measured: acute emergency situation (4 hours)
Secondary outcomes (3)
Emergency management metrics
Time metrics related to the emergency call treatment (within 4 hours after call)
Measured: acute emergency situation (within 4 hours after call)
Clinical Outcome on day 90
modified Rankin for patients with brain disease
Measured: 90 days
Clinical Outcome on day 90
EQ-5D5L
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start29 Mar 2021
- Primary completion29 Sep 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 836 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Phillips
- Sponsor type
- Other government
- Collaborators
- Universität des Saarlandes, East Suffolk and North Essex NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Daniel Phillips, East of England Ambulance Service NHS Trust
- Investigators
- Silke Walter, Prof, Principal investigator, Universität des Saarlandes, EEAST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330715
- Sponsor's protocol ID
- 292195
- Acronym
- AMSU
- Status last verified
- Apr 2022
- First submitted
- 3 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Mobile Stroke Unit for Pre-hospital Emergency Management
- ClinicalTrials.gov ID
- NCT05330715
- Acronym / sponsor ID
- AMSU / 292195
- Conditions
- Stroke, Acute, Emergencies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 836 participants (estimated)
- Lead sponsor
- Daniel PhillipsOther government
- Collaborators
- Universität des Saarlandes, East Suffolk and North Essex NHS Foundation Trust
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 29 Sep 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Apr 2022 (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.
Emergency department overcrowding is a major challenge in medicine, leading to a delay in diagnosis and treatment for the patient due to long waiting times. This is very relevant for diseases like acute stroke and other emergencies. The Advanced Mobile Stroke Unit is an ambulance equipped with additional devices to diagnose and treat patients at the emergency site. Patients with less severe conditions can be diagnosed and safely left at home. The objectives of this project are to investigate whether the Advanced Mobile Stroke Unit compared to a normal ambulance enables more accurate triage of patients (treatment at home vs hospital vs specialist vs A\&E). The Advanced Mobile Stroke Unit ambulance will be used in a random order of weeks and this will be compared to weeks with normal ambulances. The study will be carried out by the East of England Ambulance Service NHS Trust in collaboration with the East Suffolk and North Essex NHS Foundation Trust in the East of England. The project is a collaboration with Saarland University, Germany,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Mobile Stroke Unit | Other | Other: ManagementPrehospital treatment of patients with an advanced Mobile Stroke Unit. The advanced Mobile Stroke Unit is an ambulance equipped with a computed tomography scanner, and additional diagnostic devices, such as point-of-care-laboratory and telemedicine to enable the team to diagnose and initiated specialised treatment of emergency patients at the emergency site. |
| Conventional ambulance | Other | Other: ManagementPrehospital emergency care with conventional ambulances. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute emergency patients 18 years or older, who are identified via the national emergency telephone number 999 or 111with suspected severe medical emergency condition, which is categorised as: breathing problem, seizure, falls with head trauma, headache, sick person with suspected infection, stroke, unconsciousness
- calls Monday to Friday 9am to 5 pm
- written informed consent
Key exclusion criteria (4 listed)
- terminally ill patients
- pregnant patients
- patients in cardiac arrest
- patients in custody of Her Majesty's prison service
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 |
|---|---|---|
| ManagementComparison if different strategies to manage acute emergencies in the pre-hospital setting. | Other | Advanced Mobile Stroke Unit, Conventional ambulance |
Primary outcome
Number of patients requiring hospital attendance within 4h of acute emergency situation
Time frame: acute emergency situation (4 hours)
Patient attendance at hospital related to the emergency call (within 4hours) will be assessed
3 secondary outcomes
Emergency management metrics
Time frame: acute emergency situation (within 4 hours after call)
Clinical Outcome on day 90
Time frame: 90 days
Clinical Outcome on day 90
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
Silke Walter, Prof principal investigator
Universität des Saarlandes, EEAST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management in people with Stroke, Acute and Emergencies, run by Daniel Phillips at 1 site in United Kingdom.
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 3 inclusion and 4 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 15 Apr 2022. 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 United Kingdom. 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 Daniel Phillips (+447971059148, daniel.phillips@eastamb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients requiring hospital attendance within 4h of acute emergency situation (time frame: acute emergency situation (4 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 15 Apr 2022.