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Acute StrokeNCT02465346

"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas

A study testing MSU-based stroke management in people with Acute Stroke, run by University Hospital, Saarland at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site for hyperacute treatment and transfer to the most appropriate target hospital. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Acute Stroke
What is being tested?
MSU-based stroke management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteGermany
Study dates
Jun 2015to Feb 2018
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 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms of acute stroke reported to the EMS dispatcher office (extended FAST Score, Table I) and verified by the EMS (after glucose testing)
  • Reported onset of symptoms until call ≤ 8 hours
  • Patients with "wake up stroke"
  • Age older than 18 years
  • Patient (or representative) is willing to participate voluntarily and to sign a written informed consent.

Who cannot join

  • Cardiopulmonary unstable medical conditions requiring immediate treatment in an intensive care unit
  • Patients with preexisting severe functional impairment and disease
  • Known allergy or contraindications to contrast agents

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Neurology, University Hospital of the Saarland

    Homburg/Saar, Saarland, 66424

Other trials in Germany

About this study

Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site for hyperacute treatment and transfer to the most appropriate target hospital. The effects on reduction delays until different stroke treatments will be assessed. First estimations of cost-effectiveness will also be performed.

Read the detailed description

Stroke is a medical emergency for which "time-is-brain". Indeed, a huge body of animal experimental and clinical evidence exists that demonstrates that reducing the time to thrombolytic therapy is the most important variable in prevention of the disability. However, most stroke patients arrive to hospital too late for any type of acute stroke treatment: Only an estimated 19-60% of stroke patients present within 3 hours after symptom onset. Today, for stroke patients 3 different treatment options exist.

  1. Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective treatment for many acute stroke patients as evidenced by several large randomized trials.
  2. More recently, mechanical clot removal via catheters has been developed. There is currently increasing evidence that in obstruction of large brain vessels such endovascular treatment is superior to systemic thrombolysis in regard to recanalization rates and outcome.
  3. Patients with intracranial hemorrhage can profit if transferred to hospitals with neurosurgical treatment options such as ventricular drainage or hematoma removal.

However, each of these treatment are highly time sensitive and due the availability of endovascular and neurosurgical treatment options only in very few highly specialized neurovascular centres decision in which institution the patient should be transported is of high medical and financial relevance. The aim of this trial is to show feasibility, safety and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site and its role in decision regarding transfer to appropriate target institution, thus potentially allowing reduction of time until treatment and delays until specialized treatment also in remote regions. First estimations of cost-effectiveness will also be performed.

Conditions
Acute Stroke
Being tested
MSU-based stroke management, Control stroke management
Keywords
acute stroke, prehospital, treatment
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MSU-based stroke managementDevice

    Prehospital stroke treatment with a mobile stroke unit

  • Control stroke managementDevice

    Conventional stroke management

Study groups in NCT02465346
Study groupRoleWhat they receive
MSU-based stroke managementExperimentalThe Mobile Stroke Unit (MSU) and the conventional emergency medical Service (EMS) will meet at the emergency site. The patient's medical history, the physical examination will directly be performed by a physician. Laboratory tests will be analyzed by a point of care laboratory. CT will be performed. After performance of the acute stroke diagnostic work-up the patients and, if indicated thrombolysis, the patient will be transported according to the diagnostic results: Stroke due to large vessel occlusion or to intracranial hemorrhage-> Neurovascular centre; Stroke without large vessel occlusion or without hemorrhage-> primary hospital with regional stroke unit.
Receives: Device: MSU-based stroke management
Control stroke managementActive comparatorAfter performing patient's medical history, physical examination (reassessment of the extended Face Arm Speech Time score) and glucose testing by the (stroke trained) emergency personnel, the patient will be transported according to current best clinical practice and relevant guidelines to the next stroke unit or neurovascular centre. The hospital stroke team will be prenotified by the EMS. According to the patients needs the patient might be further transferred.
Receives: Device: Control stroke management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital

    Measured: within 3 month

Secondary outcomes (7)

  1. Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being evaluated/ treated by an interventionalist

    Measured: within 3 month

  2. Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion

    Measured: within 3 month

  3. Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon.

    Measured: within 3 month

  4. Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage

    Measured: within 3 month

  5. Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis

    Measured: within 3 month

  6. Functional neurological status (mRS) (D7, D90)

    Measured: within 3 month

  7. Proportion of secondary transfers of stroke patients between primary stroke unit and neurovascular centre in all stroke patients, and in subgroups with ischemic and hemorrhagic stroke

    Measured: within 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionNov 2017
  4. Study completionFeb 2018

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465346
Sponsor's protocol ID
USaarland
Status last verified
Jan 2019
First submitted
31 May 2015
Last updated
14 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, Roth C, Papanagiotou P, Grunwald I, Schumacher H, Helwig S, Viera J, Korner H, Alexandrou M, Yilmaz U, Ziegler K, Schmidt K, Dabew R, Kubulus D, Liu Y, Volk T, Kronfeld K, Ruckes C, Bertsch T, Reith W, Fassbender K. Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol. 2012 May;11(5):397-404. doi: 10.1016/S1474-4422(12)70057-1. Epub 2012 Apr 11.

    PubMed 22497929

  • Helwig SA, Ragoschke-Schumm A, Schwindling L, Kettner M, Roumia S, Kulikovski J, Keller I, Manitz M, Martens D, Grun D, Walter S, Lesmeister M, Ewen K, Brand J, Fousse M, Kauffmann J, Zimmer VC, Mathur S, Bertsch T, Guldner J, Magull-Seltenreich A, Binder A, Spuntrup E, Chatzikonstantinou A, Adam O, Kronfeld K, Liu Y, Ruckes C, Schumacher H, Grunwald IQ, Yilmaz U, Schlechtriemen T, Reith W, Fassbender K. Prehospital Stroke Management Optimized by Use of Clinical Scoring vs Mobile Stroke Unit for Triage of Patients With Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1484-1492. doi: 10.1001/jamaneurol.2019.2829.

    PubMed 31479116

Questions about this trial

What is this clinical trial studying?

A study testing MSU-based stroke management in people with Acute Stroke, run by University Hospital, Saarland at 1 site in Germany.

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 5 inclusion and 3 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 14 Jan 2019. 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 Germany. 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?

Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital (time frame: within 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02465346, which also lists 2 linked publications.

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 14 Jan 2019.

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