ArticlesDiagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial
Introduction
Stroke is a main cause of death worldwide and is one of the most common causes of disability in developed countries.1 About 90% of all strokes are due to cerebral ischaemia, with the remainder due to cerebral haemorrhage.2 The only approved treatment for ischaemic stroke is recanalisation of occluded arteries by thrombolysis with alteplase within the very first hours of symptom onset.3, 4, 5 However, implementation of recanalising therapy within this narrow therapeutic window is difficult to achieve in clinical practice because neurological examination, imaging, and laboratory analyses are needed so that haemorrhagic stroke and other contraindications to thrombolysis can be excluded.4, 5 An additional time-sensitive intervention for patients with acute stroke is blood-pressure management, which has been associated with improved outcome.6, 7
Less than 15–40% of patients with acute stroke arrive at the hospital early enough to receive thrombolytic treatment,8, 9, 10 and only 2–5% of patients actually receive it.11, 12 Of those patients who do receive state-of-the-art stroke treatment, outcome is closely related to the time to treatment.13, 14, 15 Management of acute stroke must be reconfigured if we are to overcome the problem of patients arriving at the hospital too late for treatment.
As a potential solution to this problem, we first designed16 and then studied in clinical practice17 the concept of bringing guideline-adherent stroke treatment directly to the emergency site, as has previously been made possible for patients with myocardial infarction.18 This strategy is based on a specialised ambulance (mobile stroke unit; MSU)16, 17, 19 equipped with a CT scanner, a point-of-care laboratory, and a telemedicine connection to the hospital. Apart from preliminary clinical observations, no systematic analysis of the benefit of this MSU approach on stroke management has been done. We postulated that in clinical practice prehospital stroke treatment would significantly reduce the detrimental delay in receipt of state-of-the-art stroke therapy. Hence we aimed to compare the times from alarm (emergency call) to therapy decision between the MSU and the optimised standard procedure.
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Participants
In accordance with our protocol, between November, 2008, and July, 2011, we did a randomised, parallel-group, single-centre study at the University Hospital of the Saarland, Homburg, Germany. For inclusion in our study, patients needed to be aged 18–80 years, have one or more stroke symptoms according to the modified recognition of stroke in the emergency room (ROSIER) scale20 (facial paresis, paresis of arm or leg, aphasia, or dysarthria) that had started within the previous 2·5 h, and have
Results
The figure shows the trial profile. Because we postulated that prehospital diagnostic work-up and stroke treatment would reduce the delay to therapy decision, we stopped our study when our predefined interim analysis showed the prespecified superiority (p<0·0015) in the primary endpoint.
All patients we assigned to the MSU group gave informed consent but two who would have been assigned to the control group did not. We did not lose any patients from our final analysis of our primary endpoint.
Discussion
Our main findings are that the strategy of prehospital stroke diagnosis and treatment allows therapy decisions a median of 35 min after alarm in clinical reality. Median time from symptom onset to intravenous thrombolysis was 72 min, representing a new timescale in acute stroke management.
Stroke is a medical emergency for which “time is brain”;14 however, most patients still arrive at hospital too late to receive necessary treatment.8, 9, 10 We show that MSU-based stroke management
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