Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial
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RIGHT (ISRCTN 66434824)
The 'Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial (RIGHT)' study is a collaborative, single centre, prospective, randomised, single-blind, blinded endpoint, parallel-group, controlled trial designed to test the feasibility of:
(i) Performing stroke trials in the pre-hospital ambulance environment safely with reruitment by paramedics; and
(ii) The safety and effect of transdermal glyceryl trinitrate (a nitric oxide donor) on blood pressure in patients with hyperacute stroke
Up to 80 patients with acute presumed stroke will be enrolled by paramedics within 4 hours of the onset of stroke and treatment will be given for 7 days. The primary outcome is blood pressure at 2 hours post-treatment. Recruitment will cease in December 2011
Status
As of 3 January 2013:
The trial has completed enrolment with 41 patients randomised in and around Nottingham (UK). All 41 patients have had their final follow-up at day 90, and the database has been cleaned and locked. Analyses have been completed and the data have been presented. The main trial publication has been published.
Funding
News
- October 2014: "New hope for victims of stroke" (pdf), Lincolnshire Echo, 30/10/2014
- March 2014: Views of Paramedics on their role in an ambulance-based trial (RIGHT) (pdf), 17/03/2014 **NEW**
- September 2013: Feasibility of an ambulance-based trial, and safety of glyceryl trinitrate in ultra-acute stroke: the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial (RIGHT) (pdf); published in Stroke, 07/06/2013 **NEW**
- December 2012: RIGHT protocol paper (pdf file)
- December 2012: RIGHT trial primary results presented at UK Stroke Forum December 2012 (pdf file)
- September 2012: Final Investigator meeting (pdf file)
- August 2012: Newsletter 11 (pdf file)
- April 2012: Completion of final follow-up.
- December 2011: Recruitment completed with 41 patients enrolled
- November 2011: Newsletter 10 (pdf file)
- November 2011: Investigator meeting: 19, 20 (Kingsmill, via telephone)
- October 2011: Newsletter 9 (pdf file)
- September 2011: Newsletter 8 (pdf file)
- September 2011: Investigator meeting: 18 (City Hospital)
- August 2011: Newsletter 7 (pdf file)
- August 2011: Investigator meeting: 17 (via telephone)
- July 2011: Newsletter 6 (pdf file)
- June 2011: Newsletter 5 (pdf file)
- May 2011: Newsletter 4 (pdf file)
- April 2011: Newsletter 3 (pdf file)
- March 2011: Newsletter 2 (pdf file)
- March 2011: Investigator meeting: 16 (Hucknall)
- February 2011: Newsletter 1 (pdf file)
- February 2011: Investigator meetings: 14, 15 (Stapleford x2)
- September 2010: Investigator meeting: 13 (East Midlands Airport)
- August 2010: Investigator meetings: 11, 12 (Hucknall, Wilford)
- June 2010: Investigator meeting: 10 (Newark)
- February 2010: Investigator meetings: 8, 9 (Hucknall x2)
- February 2010: Investigator meeting: 7 (Hucknall)
- December 2009: Investigator meeting: 6 (Edwinstowe)
- November 2009: Investigator meeting: 5 (Beechdale)
- October 2009: Investigator meetings: 2, 3, 4 (Beechdale, Hucknall, West Bridgford)
- September 2009: Investigator meeting: 1 (University Hospital)
- April 2009: Local Research Ethics approval received
Reference numbers
Documents
Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
University of Nottingham 'high level' SOPs (link)
Ethics approved documents
Protocol, v1.5 (pdf file)
Protocol, v1.4 (pdf file)
Protocol, v1.3 (pdf file)
Protocol, v1.2 (pdf file)
Protocol, v1.1 (pdf file)
Protocol, v1.0 draft (pdf file)
Forms
Patient details form, v1.0 (doc)
Ambulance baseline form, v1.1 (doc)
Hospital baseline form, v1.3 (doc)
Day 7 form, v1.3 (doc)
Serious Adverse Event form, v1.0 (doc)
Hospital events form, v1.2 (doc)
90-day follow-up form, v1.0 (doc)
Sheet for attaching Omron printouts v1.3 (doc)
Details for FAST-positive patient not recruited into trial, v1.1 (doc)
Hospital Non-Trial Participants Form, v1.0 (doc)
Supporting documents
RIGHT trial protocol paper (pdf file)
RIGHT trial primary results presented at UK Stroke Forum December 2012 (pdf file)
ISRCTN: 66434824, 15/9/2008 (pdf file)
NRES/LREC: approval letter from LREC, 8/4/2009 (pdf file)
NRES/LREC: response letter to LREC, 29/3/2009 (pdf file)
NRES/LREC: approval letter (initial) from LREC, 9/2/2009 (pdf file)
NRES/LREC: application form to LREC, 23/12/2008 (pdf file)
NRES/LREC: response letter to LREC, 17/12/2008 (pdf file)
NRES/LREC: rejection letter from LREC, 5/3/2008 (pdf file)
MHRA: approval letter, 17/1/2011, qualitative substudy (pdf file)
MHRA: approval letter, 16/2/2009 (pdf file)
MHRA: application form to MHRA, 14/1/2009 (pdf file)
MHRA: sample label, 2008 (pdf file)
MHRA: rejection letter, 27/2/2008 & 13/10/2008 (pdf file)
IMP: description, 11/1/2008 (pdf file)
EUDRACT: number 2007-004766-40, 11/1/2008 (pdf file)
R&D: Nottingham University Hospitals NHS Trust, number 08SR003, 05/10/2009 (pdf file)
R&D: East Midlands Ambulance Service NHS Trust, number 09/H0409/5, 18/09/2009 (pdf file)
Sponsor/University of Nottingham: agreement, 23/4/2009 (pdf file)
Sponsor/University of Nottingham: approval letter to MHRA, 12/1/2009 (pdf file)
Insurance cover (UK) for sponsor: letter, 1/8/2008 - 31/7/2009 (pdf file)
Training documents
Training: Paramedic (pptx file)
Training: New drug packs (pptx file)
Training: Sphygmocor (pdf file)
Study personnel
Trial Steering Committee:
Philip Bath (Chair, University of Nottingham), Sandeep Ankolekar (University of Nottingham), Niro Siriwardena (East Midlands Ambulance Service)
Trial Management Committee:
Philip Bath (Chief Investigator, University of Nottingham), Sandeep Ankolekar (Trial Medic, University of Nottingham), Jennifer Eardley (Trial Champion, East Midlands Ambulance Service), Andrew Harrison (Trial Champion, East Midlands Ambulance Service), Niro Siriwardena (Principal Investigator, East Midlands Ambulance Service)
Independent Events Adjudicator:
Niki Sprigg (University of Nottingham)
Contact details
RIGHT Trial Office
Stroke, Division of Clinical Neuroscience
University of Nottingham
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham NG5 1PB
UK
Telephone: +44 (0)115 823 1770
Fax: +44 (0)115 823 1771
E-mail: Sandeep Ankolekar
Written by Philip Bath, last updated by Dawn Hazle 18 May 2015
