Clinical trial NCT02465346: "Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
Official title: "Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: acute stroke
prehospital
treatment
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. The effects on reduction delays until different stroke treatments will be assessed. First estimations of cost-effectiveness will also be performed.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital
timeFrame: within 3 month
Secondary outcomes:
measure: Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being evaluated/ treated by an interventionalist
timeFrame: within 3 month
measure: Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion
timeFrame: within 3 month
measure: Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon.
timeFrame: within 3 month
measure: Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage
timeFrame: within 3 month
measure: Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis
timeFrame: within 3 month
measure: Functional neurological status (mRS) (D7, D90)
timeFrame: within 3 month
measure: 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
timeFrame: within 3 month
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Department of Neurology, University Hospital of the Saarland
state: Saarland
Study officials:
affiliation: Department of Neurology, Saarland University
name: Klaus C Fassbender, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.