The ‘Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial’ (RIGHT)

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Project title The ‘Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial’ (RIGHT)
Funding body Nottingham University Hospitals Charity
Total funding £9,038
Team
  • Dr Sandeep Ankolekar, Division of Stroke, University of Nottingham,
  • Dr Chamila Geeganage, Division of Stroke, University of Nottingham,
  • Lynn Stokes. Division of Stroke, University of Nottingham,
  • Dr Gillian Sare, Department of Neurology, Nottingham University Hospitals NHS Trust
  • Ruth Parry, School of Nursing, Midwifery, and Physiotherapy, University of Nottingham
  • Professor Niroshan Siriwardena, School of Health & Social Care, University of Lincoln
  • Professor Philip Bath, Stroke Trials Unit, Division of Stroke, University of Nottingham.
Overarching aim The primary aim was to assess the feasibility of using ambulance service practitioners to assess and deliver treatments for stroke in the ultra-acute setting after stroke. The secondary aim was to assess the effect of GTN use in ultra-acute stroke on safety, clinical, functional, and haemo-dynamic outcomes.
Objectives Primary objectives

  • To report the proportion of randomised patients with a final diagnosis of ischaemic stroke, primary intra-cerebral haemorrhage, or transient ischaemic attack.
  • To assess the additional time taken by research paramedics for study related procedures prior to hospital admission.
  • To report the experiences, perceptions and challenges of a purposive sample of participating paramedics around facilitators and barriers to recruitment of study participants.
  • To assess the proportion of patients randomised and treated according to protocol.
  • To assess the characteristics of patients screened by the paramedics for inclusion to the RIGHT study.

Secondary objectives

  • To assess the safety and tolerability of GTN in suspected ultra-acute stroke.
  • To compare the difference in peripheral blood pressure, central blood pressure, heart rate, and its derivatives between patients randomised to GTN or no GTN.
  • To compare the difference between GTN and no GTN in death, disability, dependency, mood, cognition, and quality of life.
Methods
  • RIGHT is an ambulance-based, prospective, open label, single-blind, single city, randomised controlled trial with blinded outcome assessment.
  • Adult patients with suspected stroke presenting to research trained paramedics and fulfilling the study criteria were eligible for recruitment.
  • The study intervention is transdermal Glyceryl Trinitrate (GTN) patch (5 mg) or none (control). GTN is given in the form of Nitro-Dur 0.2 mg/hr (Schering-Plough Ltd) with the patch placed on the back or shoulder. Standard NHS supplies are used.
  • Semi-structured interviews were carried out with 14 paramedics around the process of recruitment. The interviews were  transcribed verbatim, and analysed using thematic content analysis.
Outcomes

Primary outcomes

Comparison of systolic blood pressure at two hours post randomisation between GTN and no GTN groups. This outcome was chosen since it represents the sum of the trial feasibility and intervention, that is, the ability to identify, recruit, randomise, treat with GTN or control, and make measurements in patients with ultra-acute presumed stroke in an ambulance setting, and hand them over to hospital staff. The two hour time reflects the time to peak effect for GTN.

Secondary outcomes explored, comparison between treatment groups including:

  • Haemo-dynamic effects (i.e., BP, heart-rate) on days 1 – 7;
  • Stroke impairment (Scandinavian Stroke Scale);
  • Recurrence or symptomatic intracranial events and extra-cranial events;
  • Levels of dependency (Rankin Scale) and/ or disability (Barthel index)
  • Hospital events; Lengths of stay and discharge disposition.
Outputs

Publications

Ankolekar, Sandeep and Fuller, Michael and Cross, Ian and Renton, Cheryl and Cox, Patrick and Sprigg, Nikola and Siriwardena, A. Niroshan andBath, 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.

Ankolekar, Sandeep and Parry, Ruth and Sprigg, Nikola and Siriwardena, A. Niroshan and Bath, Philip M. W. (2014) Views of paramedics on their role in an out-of-hospital ambulance-based trial in ultra-acute stroke: qualitative data from the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT). Annals of Emergency Medicine.

Ankolekar, Sandeep and Sare, Gillian and Geeganage, Chamila and Fuller, Michael and Stokes, Lynn and Sprigg, Nikola and Parry, Ruth andSiriwardena, A. Niroshan and Bath, Philip M. W. (2012) Determining the feasibility of ambulance-based randomised controlled trials in patients with ultra-acute stroke: study protocol for the “Rapid Intervention with GTN in Hypertensive Stroke Trial” (RIGHT, ISRCTN66434824). Stroke Research and Treatment, 2012.

Trial website: http://www.right-trial.org/ 

Impact The RIGHT trial, the world’s first completed ambulance-based randomised controlled stroke trial, tested using GTN patches within 4 hours of a stroke by recruiting and treating 41 patients in the ambulance. This has led to funding by the British Heart Foundation of a definitive trial of prehospital GTN patches in ultra-acute stroke.

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