title: Feasibility of an ambulance-based stroke trial, and safety of glyceryl trinitrate in ultra-acute stroke: the rapid intervention with glyceryl trinitrate in Hypertensive Stroke Trial (RIGHT, ISRCTN66434824).
abstract: OBJECTIVE
  The practicalities of doing ambulance-based trials where paramedics perform all aspects of a clinical trial involving patients with ultra-acute stroke have not been assessed.
  
  
  METHODS
  We performed a randomized controlled trial with screening, consent, randomization, and treatment performed by paramedics prior to hospitalization. Patients with probable ultra-acute stroke (<4 hours) and systolic blood pressure (SBP) >140 mm Hg were randomized to transdermal glyceryl trinitrate (GTN; 5 mg/24 hours) or none (blinding under gauze dressing) for 7 days with the first dose given by paramedics. The primary outcome was SBP at 2 hours.
  
  
  RESULTS
  Of a planned 80 patients, 41 (25 GTN, 16 no GTN) were enrolled >22 months with median age [interquartile range] 79 [16] years; men 22 (54%); SBP 168 [46]; final diagnosis: stroke 33 (80%) and transient ischemic attack 3 (7%). Time to randomization was 55 [75] minutes. After treatment with GTN versus no GTN, SBP at 2 hours was 153 [31] versus 174 [27] mm Hg, respectively, with difference -18 [30] mm Hg (P=0.030). GTN improved functional outcome with a shift in the modified Rankin Scale by 1 [3] point (P=0.040). The rates of death, 4 (16%) versus 6 (38%; P=0.15), and serious adverse events, 14 (56%) versus 10 (63%; P=0.75), did not differ between GTN and no GTN.
  
  
  CONCLUSIONS
  Paramedics can successfully enroll patients with ultra-acute stroke into an ambulance-based trial. GTN reduces SBP at 2 hours and seems to be safe in ultra-acute stroke. A larger trial is needed to assess whether GTN improves functional outcome.
  
  
  BACKGROUND
  http://www.controlled-trials.com/ISRCTN66434824/66434824. Unique identifier: 66434824.
authors.affiliation: From the Stroke Trials Unit, Division of Stroke, University of Nottingham, United Kingdom (S.A., C.R., P.C., N.S., P.M.B.); Department of Stroke, Nottingham University Hospitals NHS Trust, United Kingdom (S.A., N.S., P.M.B.); East Midlands Ambulance Service NHS Trust, Nottingham, United Kingdom (M.F., I.C., A.N.S.); and School of Health and Social Care, University of Lincoln, United Kingdom (A.N.S.).
authors.forename: Sandeep
authors.initials: S
authors.lastname: Ankolekar
authors.forename: Michael
authors.initials: M
authors.lastname: Fuller
authors.forename: Ian
authors.initials: I
authors.lastname: Cross
authors.forename: Cheryl
authors.initials: C
authors.lastname: Renton
authors.forename: Patrick
authors.initials: P
authors.lastname: Cox
authors.forename: Nikola
authors.initials: N
authors.lastname: Sprigg
authors.forename: A Niroshan
authors.initials: AN
authors.lastname: Siriwardena
authors.forename: Philip M
authors.initials: PM
authors.lastname: Bath
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000488:Allied Health Personnel; D000552:Ambulances; D001458:Bandages; D001794:Blood Pressure; D015331:Cohort Studies; D004635:Emergency Medicine / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006439:Hemodynamics; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy; D008297:Male; D005996:Nitroglycerin / Q000009:adverse effects* / Q000627:therapeutic use*; D061214:Patient Safety; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D013599:Systole; D016896:Treatment Outcome
chemical_list: D005996:Nitroglycerin
keywords: ambulances; blood pressure; nitroglycerin; prehospital; stroke