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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • MSU-based stroke management Device
    Intervention Desc: Prehospital stroke treatment with a mobile stroke unit
    ARM 1: Kind: Experimental
    Label: MSU-based stroke management
    Description: 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 stroke-trained physician examination. 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.
  • Control stroke management Device
    Intervention Desc: Conventional stroke management
    ARM 1: Kind: Experimental
    Label: Control stroke management
    Description: 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 to the closest stroke centre - according to current best clinical practice. The hospital stroke team will be prenotified by the EMS. There, the patient will directly be further examined, including CT, if indicated, be treated with IV rt-PA and, in case of need of further specialized care, be transferred to the most appropriate institution.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of stroke patients with accurate decision regarding transfer to the most appropriate target hospital within 3 month No
Primary Proportion of secondary transfers of stroke patients between primary stroke units and neurovascular centre within 3 month No
Secondary Proportion of patients with large vessel occlusion a) being directly transferred to a neurovascular centre, and b) being treated by an interventionalist within 3 month No
Secondary Time between symptom onset/alarm and treatment by an interventional radiologist in case of large vessel occlusion within 3 month No
Secondary Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) treated by a neurosurgeon. within 3 month No
Secondary Time between symptom onset/alarm and treatment by a neurosurgeon in case of haemorrhage within 3 month No
Secondary Proportion of patients treated with rt-PA and time between symptom onset/ alarm and start of thrombolysis within 3 month No
Secondary Functional neurological status (mRS) (D7, D90) within 3 month No
Secondary 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 No
Secondary Time between symptom onset/alarm and evaluation/treatment by an interventional radiologist in case of large vessel occlusion within 3 month No
Secondary Proportion of patients with haemorrhage being a) directly transferred to a neurovascular centre, and being b) evaluated/treated by a neurosurgeon. within 3 month No
Secondary Time between symptom onset/alarm and evaluation/treatment by a neurosurgeon in case of haemorrhage within 3 month No
Secondary 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 No

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