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)

Ankolekar, Sandeep and Sare, Gillian and Geeganage, Chamila and Fuller, Michael and Stokes, Lynn and Sprigg, Nikola and Parry, Ruth and Siriwardena, 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 . pp. 1-10. ISSN 2090-8105

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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)
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Official URL: http://www.hindawi.com/journals/srt/2012/385753/

Abstract

Background. Time from acute stroke to enrolment in clinical trials needs to be reduced to improve the chances of finding effective treatments. No completed randomised controlled trials of ambulance-based treatment for acute stroke have been reported in the UK, and the practicalities of recruiting, consenting, and treating patients are unknown. Methods. RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. The trial will assess feasibility of using ambulance services to deliver ultra-acute stroke treatments; a secondary aim is to assess the effect of glyceryl trinitrate (GTN) on haemodynamic variables and functional outcomes. Initial consent, randomisation, and treatment are performed by paramedics prior to hospitalisation. Patients with ultra-acute stroke (≤4 hours of onset) are randomised to transdermal GTN (5mg/24 hours)or gauze dressing daily for 7 days. The primary outcome is systolic blood pressure at 2 hours. Secondary outcomes include feasibility, haemodynamics, dependency, and other functional outcomes. A nested qualitative study is included. Trial Status. The trial has all relevant ethics and regulatory approvals and recruitment started on February 15, 2010. The trial stopped recruitment in December 2011 after 41 patients were recruited. Trial Registration. The trial registration number is ISRCTN66434824 and EudraCT
number is 2007-004766-40.

Item Type:Article
Additional Information:Background. Time from acute stroke to enrolment in clinical trials needs to be reduced to improve the chances of finding effective treatments. No completed randomised controlled trials of ambulance-based treatment for acute stroke have been reported in the UK, and the practicalities of recruiting, consenting, and treating patients are unknown. Methods. RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. The trial will assess feasibility of using ambulance services to deliver ultra-acute stroke treatments; a secondary aim is to assess the effect of glyceryl trinitrate (GTN) on haemodynamic variables and functional outcomes. Initial consent, randomisation, and treatment are performed by paramedics prior to hospitalisation. Patients with ultra-acute stroke (≤4 hours of onset) are randomised to transdermal GTN (5mg/24 hours)or gauze dressing daily for 7 days. The primary outcome is systolic blood pressure at 2 hours. Secondary outcomes include feasibility, haemodynamics, dependency, and other functional outcomes. A nested qualitative study is included. Trial Status. The trial has all relevant ethics and regulatory approvals and recruitment started on February 15, 2010. The trial stopped recruitment in December 2011 after 41 patients were recruited. Trial Registration. The trial registration number is ISRCTN66434824 and EudraCT number is 2007-004766-40.
Keywords:randomised controlled trial, glyceryl trinitrate (GTN), stroke, ambulance service, hypertension, prehospital care, oaopen
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:6726
Deposited By: Niro Siriwardena
Deposited On:29 Oct 2012 23:17
Last Modified:29 May 2014 08:32

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