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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSU-based stroke management | Experimental | 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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| Control stroke management | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSU-based stroke management | Device | Prehospital stroke treatment with a mobile stroke unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital | within 3 month |
| Measure | Description | 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 | within 3 month | |
| Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus C Fassbender, MD | Department of Neurology, Saarland University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University Hospital of the Saarland | Homburg/Saar | Saarland | 66424 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22497929 | Result | 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. | |
| 31479116 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Control stroke management | Device | Conventional stroke management |
|
| within 3 month |
| Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon. | within 3 month |
| Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage | within 3 month |
| Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis | within 3 month |
| Functional neurological status (mRS) (D7, D90) | within 3 month |
| 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 | within 3 month |
| Derived |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |