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)
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, c...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2012-01-01
|
| Series: | Stroke Research and Treatment |
| Online Access: | http://dx.doi.org/10.1155/2012/385753 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832555544102043648 |
|---|---|
| author | Sandeep Ankolekar Gillian Sare Chamila Geeganage Michael Fuller Lynn Stokes Nikola Sprigg Ruth Parry A. Niroshan Siriwardena Philip M. W. Bath |
| author_facet | Sandeep Ankolekar Gillian Sare Chamila Geeganage Michael Fuller Lynn Stokes Nikola Sprigg Ruth Parry A. Niroshan Siriwardena Philip M. W. Bath |
| author_sort | Sandeep Ankolekar |
| collection | DOAJ |
| description | 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 (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. |
| format | Article |
| id | doaj-art-81e46fae1d8c44549d86d9fcb63f9019 |
| institution | Kabale University |
| issn | 2090-8105 2042-0056 |
| language | English |
| publishDate | 2012-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stroke Research and Treatment |
| spelling | doaj-art-81e46fae1d8c44549d86d9fcb63f90192025-02-03T05:48:01ZengWileyStroke Research and Treatment2090-81052042-00562012-01-01201210.1155/2012/385753385753Determining 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)Sandeep Ankolekar0Gillian Sare1Chamila Geeganage2Michael Fuller3Lynn Stokes4Nikola Sprigg5Ruth Parry6A. Niroshan Siriwardena7Philip M. W. Bath8Stroke Trials Unit, Division of Stroke, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham NG5 1PB, UKDepartment of Neurology, Nottingham University Hospitals NHS Trust, Nottingham, UKStroke Trials Unit, Division of Stroke, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham NG5 1PB, UKEast Midlands Ambulance Service NHS Trust, Nottingham, UKStroke Trials Unit, Division of Stroke, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham NG5 1PB, UKStroke Trials Unit, Division of Stroke, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham NG5 1PB, UKSchool of Nursing, Midwifery, and Physiotherapy, University of Nottingham, Nottingham, UKEast Midlands Ambulance Service NHS Trust, Nottingham, UKStroke Trials Unit, Division of Stroke, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham NG5 1PB, UKBackground. 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.http://dx.doi.org/10.1155/2012/385753 |
| spellingShingle | Sandeep Ankolekar Gillian Sare Chamila Geeganage Michael Fuller Lynn Stokes Nikola Sprigg Ruth Parry A. Niroshan Siriwardena Philip M. W. Bath 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 |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | http://dx.doi.org/10.1155/2012/385753 |
| work_keys_str_mv | AT sandeepankolekar determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT gilliansare determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT chamilageeganage determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT michaelfuller determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT lynnstokes determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT nikolasprigg determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT ruthparry determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT aniroshansiriwardena determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 AT philipmwbath determiningthefeasibilityofambulancebasedrandomisedcontrolledtrialsinpatientswithultraacutestrokestudyprotocolfortherapidinterventionwithgtninhypertensivestroketrialrightisrctn66434824 |