StrokePreSSUB IINCT02270541
Prehospital Study at the Universitair Ziekenhuis Brussel II
A study testing Telemedicine in people with Stroke, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Feb 2017
- 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
- Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
- Age >= 18 years
- Suspicion of acute stroke with symptom onset < 12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.
Who cannot join
- Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
About this study
Official title: Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke
Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.
Read the detailed description
The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.
The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.
- Conditions
- Stroke
- Being tested
- Telemedicine
- Keywords
- Telemedicine, Prehospital, Emergency Medicine, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
In-ambulance telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures. |
| Telemedicine | Experimental | In-ambulance teleconsultation by a stroke expert aiming to support the Paramedic Intervention Team by focusing on patient identification, obtaining homeostasis (optimal control of blood pressure, blood oxygenation, temperature, heart rate and rhythm, glycemia), assessment of the patient's neurological status, stroke diagnosis, hospital notification, and patient selection for specific stroke treatment. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Call-to-brain imaging time
Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.
Measured: within 2 hours
Secondary outcomes (3)
Medical events during in-ambulance telemedicine
Prevalence of medical events diagnosed and corrected during in-ambulance telemedicine (e.g. blood oxygen desaturation, arterial hypertension, arterial hypotension, hypoglycemia, hyperglycemia, cardiac arrhythmia, decreased level of consciousness, hyperthermia)
Measured: within 2 hours
Recanalisation therapy
Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy).
Measured: upto 8 hours
Clinical outcome
Assessment of the functional status
Measured: upto 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Vrije Universiteit Brussel, Brussels Institute for Research and Innovation (INNOVIRIS), King Baudouin Foundation
- Responsible party
- Principal investigator, Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel
- Investigators
- Jacques De Keyser, MD PhD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270541
- Sponsor's protocol ID
- 2014-003463-38
- Other IDs
- 2014
- Acronym
- PreSSUB II
- Status last verified
- Mar 2016
- First submitted
- 16 Oct 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke
- ClinicalTrials.gov ID
- NCT02270541
- Acronym / sponsor ID
- PreSSUB II / 2014-003463-38
- Conditions
- Stroke
- Keywords
- Telemedicine, Prehospital, Emergency Medicine, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Vrije Universiteit Brussel, Brussels Institute for Research and Innovation (INNOVIRIS), King Baudouin Foundation
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- 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.
Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.
Detailed description
The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.
The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures. |
| Telemedicine | Experimental | Other: TelemedicineIn-ambulance teleconsultation by a stroke expert aiming to support the Paramedic Intervention Team by focusing on patient identification, obtaining homeostasis (optimal control of blood pressure, blood oxygenation, temperature, heart rate and rhythm, glycemia), assessment of the patient's neurological status, stroke diagnosis, hospital notification, and patient selection for specific stroke treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
- Age >= 18 years
- Suspicion of acute stroke with symptom onset < 12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.
Key exclusion criteria (1 listed)
- Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.
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 |
|---|---|---|
| TelemedicineIn-ambulance telemedicine | Other | Telemedicine |
Primary outcome
Call-to-brain imaging time
Time frame: within 2 hours
Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.
3 secondary outcomes
Medical events during in-ambulance telemedicine
Time frame: within 2 hours
Recanalisation therapy
Time frame: upto 8 hours
Clinical outcome
Time frame: upto 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Jacques De Keyser, MD PhD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Stroke, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 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 2 Mar 2016. 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 Belgium. 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?
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?
Call-to-brain imaging time (time frame: within 2 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 2 Mar 2016.