title: Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial.
abstract: OBJECTIVE
  Time to thrombolysis is crucial for outcome in acute ischemic stroke.
  
  
  OBJECTIVE
  To determine if starting thrombolysis in a specialized ambulance reduces delays.
  
  
  METHODS
  In the Prehospital Acute Neurological Treatment and Optimization of Medical care in Stroke Study (PHANTOM-S), conducted in Berlin, Germany, we randomly assigned weeks with and without availability of the Stroke Emergency Mobile (STEMO) from May 1, 2011, to January 31, 2013. Berlin has an established stroke care infrastructure with 14 stroke units. We included 6182 adult patients (STEMO weeks: 44.3% male, mean [SD] age, 73.9 [15.0] y; control weeks: 45.2% male, mean [SD] age, 74.3 [14.9] y) for whom a stroke dispatch was activated.
  
  
  METHODS
  The intervention comprised an ambulance (STEMO) equipped with a CT scanner, point-of-care laboratory, and telemedicine connection; a stroke identification algorithm at dispatcher level; and a prehospital stroke team. Thrombolysis was started before transport to hospital if ischemic stroke was confirmed and contraindications excluded.
  
  
  METHODS
  Primary outcome was alarm-to-thrombolysis time. Secondary outcomes included thrombolysis rate, secondary intracerebral hemorrhage after thrombolysis, and 7-day mortality.
  
  
  RESULTS
  Time reduction was assessed in all patients with a stroke dispatch from the entire catchment area in STEMO weeks (3213 patients) vs control weeks (2969 patients) and in patients in whom STEMO was available and deployed (1804 patients) vs control weeks (2969 patients). Compared with thrombolysis during control weeks, there was a reduction of 15 minutes (95% CI, 11-19) in alarm-to-treatment times in the catchment area during STEMO weeks (76.3 min; 95% CI, 73.2-79.3 vs 61.4 min; 95% CI, 58.7-64.0; P < .001). Among patients for whom STEMO was deployed, mean alarm-to-treatment time (51.8 min; 95% CI, 49.0-54.6) was shorter by 25 minutes (95% CI, 20-29; P < .001) than during control weeks. Thrombolysis rates in ischemic stroke were 29% (310/1070) during STEMO weeks and 33% (200/614) after STEMO deployment vs 21% (220/1041) during control weeks (differences, 8%; 95% CI, 4%-12%; P < .001, and 12%, 95% CI, 7%-16%; P < .001, respectively). STEMO deployment incurred no increased risk for intracerebral hemorrhage (STEMO deployment: 7/200; conventional care: 22/323; adjusted odds ratio [OR], 0.42, 95% CI, 0.18-1.03; P = .06) or 7-day mortality (9/199 vs 15/323; adjusted OR, 0.76; 95% CI, 0.31-1.82; P = .53).
  
  
  CONCLUSIONS
  Compared with usual care, the use of ambulance-based thrombolysis resulted in decreased time to treatment without an increase in adverse events. Further studies are needed to assess the effects on clinical outcomes.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01382862.
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin2Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Martin
authors.initials: M
authors.lastname: Ebinger
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin2Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Winter
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin.
authors.forename: Matthias
authors.initials: M
authors.lastname: Wendt
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin.
authors.forename: Joachim E
authors.initials: JE
authors.lastname: Weber
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin.
authors.forename: Carolin
authors.initials: C
authors.lastname: Waldschmidt
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin2Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Michal
authors.initials: M
authors.lastname: Rozanski
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin2Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Alexander
authors.initials: A
authors.lastname: Kunz
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin.
authors.forename: Peter
authors.initials: P
authors.lastname: Koch
authors.affiliation: Vivantes-Klinikum im Friedrichshain, Rettungsstelle, Berlin.
authors.forename: Philipp A
authors.initials: PA
authors.lastname: Kellner
authors.affiliation: Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Daniel
authors.initials: D
authors.lastname: Gierhake
authors.affiliation: Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Kersten
authors.initials: K
authors.lastname: Villringer
authors.affiliation: Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Jochen B
authors.initials: JB
authors.lastname: Fiebach
authors.affiliation: Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin4Department for Biostatistics and Clinical Epidemiology, Charité-Universitätsmedizin Berlin.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Grittner
authors.affiliation: Rhön-Klinikum-Klinikum Frankfurt (Oder), Frankfurt (Oder).
authors.forename: Andreas
authors.initials: A
authors.lastname: Hartmann
authors.affiliation: Vivantes-Auguste-Viktoria-Klinikum, Berlin.
authors.forename: Bruno-Marcel
authors.initials: BM
authors.lastname: Mackert
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin2Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin7ExcellenceCluster NeuroCure, Charité-Universitätsmedizin Berlin8German Center for Neurodegenerative Diseases (DZNE), Be.
authors.forename: Matthias
authors.initials: M
authors.lastname: Endres
authors.affiliation: Department of Neurology, Charité-Universitätsmedizin Berlin2Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin Berlin.
authors.forename: Heinrich J
authors.initials: HJ
authors.lastname: Audebert
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000552:Ambulances; D002545:Brain Ischemia / Q000150:complications*; D004632:Emergency Medical Services; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology*; D016019:Survival Analysis; D017216:Telemedicine; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods; D013997:Time Factors; D014057:Tomography, X-Ray Computed