Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial

RIGHT (ISRCTN 66434824)


2013, January: Recruitment and follow-up of 41 patients is complete and the final Investigator meeting has been held. The protocol paper has been published.

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


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

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