Ankolekar et al 2012 feasibility RIGHT.pdf (1.6 MB)
Download fileDetermining 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)
journal contribution
posted on 2018-04-23, 15:27 authored by Sandeep Ankolekar, Gillian Sare, Chamila Geeganage, Michael Fuller, Lynn Stokes, Nikola Sprigg, Ruth Parry, A. Niroshan Siriwardena, Philip M. BathBackground. 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 (5 mg/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.
Funding
RIGHT is funded by the Nottingham University Hospitals NHS Trust R and D Pump Priming competition, and by the Division of Stroke. S. Ankolekar is funded by the UK Medical Research Council (Grant G0501797).
History
School
- Social Sciences
Department
- Communication, Media, Social and Policy Studies
Published in
Stroke Research and TreatmentVolume
2012Pages
1 - 10Citation
ANKOLEKAR, S. ... et al, 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, Vol. 2012, Article ID 385753.Publisher
Hindawi Publishing Corporation © The AuthorsVersion
- VoR (Version of Record)
Publisher statement
This work is made available according to the conditions of the Creative Commons Attribution 3.0 Unported (CC BY 3.0) licence. Full details of this licence are available at: http://creativecommons.org/licenses/by/3.0/Publication date
2012Notes
This is an Open Access Article. It is published by Hindawi Publishing Corporation under the Creative Commons Attribution 3.0 Unported Licence (CC BY). Full details of this licence are available at: https://creativecommons.org/licenses/by/3.0/ISSN
2090-8105eISSN
2042-0056Publisher version
Language
- en