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)

Ankolekar, Sandeep and Fuller, Michael and Cross, Ian and Renton, Cheryl and Cox, Patrick and Sprigg, Nikola and Siriwardena, A. Niroshan and Bath, Philip M. W. (2013) 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). Stroke, 44 (11). pp. 3120-3128. ISSN 0039-2499

Full content URL: http://stroke.ahajournals.org/content/early/2013/0...

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Feasibility of an ambulance-based trial, and safety of glyceryl trinitrate, in patients with ultra-acute stroke: the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial’ (RIGHT, ISRCTN66434824)

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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.

Additional Information:Published online before print 3 September 2013
Keywords:ambulances, blood pressure, nitroglycerin, prehospital, stroke
Subjects:B Subjects allied to Medicine > B990 Subjects Allied to Medicine not elsewhere classified
B Subjects allied to Medicine > B780 Paramedical Nursing
A Medicine and Dentistry > A300 Clinical Medicine
Divisions:College of Social Science > School of Health & Social Care
ID Code:11809
Deposited On:20 Sep 2013 20:22

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