- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02465346
"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
Study Overview
Status
Conditions
Intervention / Treatment
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.
- Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective treatment for many acute stroke patients as evidenced by several large randomized trials.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saarland
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Homburg/Saar, Saarland, Germany, 66424
- Department of Neurology, University Hospital of the Saarland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MSU-based stroke management
The 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.
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Prehospital stroke treatment with a mobile stroke unit
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Active Comparator: Control stroke management
After 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.
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Conventional stroke management
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital
Time Frame: within 3 month
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within 3 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being evaluated/ treated by an interventionalist
Time Frame: within 3 month
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within 3 month
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Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion
Time Frame: within 3 month
|
within 3 month
|
Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon.
Time Frame: within 3 month
|
within 3 month
|
Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage
Time Frame: within 3 month
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within 3 month
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Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis
Time Frame: within 3 month
|
within 3 month
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Functional neurological status (mRS) (D7, D90)
Time Frame: within 3 month
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within 3 month
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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
Time Frame: within 3 month
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within 3 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Klaus C Fassbender, MD, Department of Neurology, Saarland University
Publications and helpful links
General 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. Erratum In: Lancet Neurol. 2012 Jun;11(6):483.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USaarland
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