Feasibility of an Ambulance-Based Stroke Trial, and Safety of Glyceryl Trinitrate in Ultra-Acute Stroke

Talk to your ER doctors and hospital to see if this makes sense to implement. If you don't ask I can 100% guarantee they won't do anything for 30 years.
http://stroke.ahajournals.org/content/44/11/3120.abstract.html?etoc

1. The Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT, ISRCTN66434824)

   1. Sandeep Ankolekar, MD, MRCP;
   2. Michael Fuller, DipHE;
   3. Ian Cross, DipHE;
   4. Cheryl Renton, MSc;
   5. Patrick Cox, RGN;
   6. Nikola Sprigg, MD, MRCP;
   7. A. Niroshan Siriwardena, PhD, FRCGP;
   8. Philip M. Bath, MD, FRCP

   + Author Affiliations

   1. 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.).

   1. Correspondence to Philip M. Bath, MD, Division of Stroke, University of Nottingham City Hospital Campus, Hucknall Rd, Nottingham NG5 1PB, United Kingdom. E-mail philip.bath@nottingham.ac.uk

   Abstract

   Background and Purpose—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.

   Clinical Trial Registration—URL: http://www.controlled-trials.com/ISRCTN66434824/66434824. Unique identifier: 66434824.