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Diagnosis and Treatment of Patients With Stroke in a Mobile Stroke Unit Versus in Hospital: A Randomised Controlled Trial
Study Questions:
What is the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy?
Methods:
The investigators conducted a randomized single-center controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit and hospital intervention. For inclusion in the study, patients needed to be between age 18-80 years and have one or more stroke symptoms that started within the previous 2.5 hours. In accordance with the week-wise randomization plan, patients received either prehospital stroke treatment in a specialized ambulance (equipped with a computed tomography [CT] scanner, point-of-care laboratory, and telemedicine connection) or optimized conventional hospital-based stroke treatment (control group) with a 7-day follow-up. Allocation was not masked from patients and investigators. The primary endpoint was time from alarm to therapy decision, which was analyzed with the Mann-Whitney U test. The secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. The investigators also assessed safety endpoints.
Results:
The investigators stopped the trial after their planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because they had met their prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 minutes (interquartile range, 31-39) versus 76 minutes (63-94), p < 0.0001; median difference 41 minutes (95% confidence interval, 36-48 minutes). The investigators also detected similar gains regarding times from alarm to end of CT, and alarm to end of laboratory analysis, and to intravenous thrombolysis for eligible ischemic stroke patients, although there was no substantial difference in number of patients who received intravenous thrombolysis or in neurological outcome. Safety endpoints seemed similar across the groups.
Conclusions:
The authors concluded that for patients with suspected stroke, treatment by the mobile stroke unit substantially reduced median time from alarm to therapy decision.
Perspective:
The primary study findings are that the strategy of prehospital stroke diagnosis and treatment allows therapy decisions a median of 35 minutes after alarm in clinical reality. Median time from symptom onset to intravenous thrombolysis was 72 minutes, which represents a new timescale in acute stroke management. However, despite the substantial differences in stroke management times, there were no significant differences between the two study groups in the number of treated patients or in neurological outcomes. The effect on clinical outcome and safety of this approach needs further study in larger multicenter trials.
Keywords: Stroke, Tomography, X-Ray Computed, Telemedicine
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