Acute Stroke Clinical Trial
Official title:
"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
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.
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.
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