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02 September 2010
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| [ Print-friendly version ] |
| The Stroke Oxygen Study: a multi-centre, prospective, randomised, open, blinded-endpoint study of routine oxygen treatment in the first 72 hours after a stroke |
| ISRCTN | ISRCTN52416964 |
| ClinicalTrials.gov identifier | |
| Public title | The Stroke Oxygen Study: a multi-centre, prospective, randomised, open, blinded-endpoint study of routine oxygen treatment in the first 72 hours after a stroke |
| Scientific title | |
| Acronym | SO2S |
| Serial number at source | 06/Q2604/109 |
| Study hypothesis |
Main Hypothesis:
Fixed dose oxygen treatment during the first three days after an acute stroke improves outcome. Secondary hypothesis: Restricting oxygen supplementation to night time only is more effective than continuous supplementation. The pilot study of this trial can be found at ISRCTN12362720 (http://www.controlled-trials.com/ISRCTN12362720). |
| Ethics approval | Ethics approval received from the Local Research Ethics Committee (Mellor House, Corporation Sreet, Stafford, ST16 3SR, UK) on the 31st October 2006 (ref: 06/Q260/109; EudraCT no: 2006-003479-11). Protocol version 2 approved on 24th January 2007 and on the 26th June 2008. |
| Study design | A multi-centre, prospective, randomised, open, blinded-endpoint study. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke, cerebral infarct, intracerebral haemorrhage, cerebrovascular disease |
| Participants - inclusion criteria |
Adult patients (either sex) are eligible for trial inclusion if they were admitted with symptoms of an acute stroke within the preceding 24 hours, and if, in the doctor’s opinion, there is no clear indication for and no clear contraindication against oxygen treatment:
1. Potential indications for oxygen treatment could be: 1.1. Oxygen saturation on air less than 90% 1.2. Hypoxia associated with acute left ventricular failure 1.3. Severe pneumonia 1.4. Pulmonary embolus 1.5. Chronic respiratory failure patients treated with long term oxygen at home 2. Potential contraindications to fixed dose oxygen treatment could be: 2.1. Type 2 respiratory failure 2.2. Very severe hypoxia 3. Medical centres are eligible for participation in the study if they admit patients with acute stroke, are able to provide oxygen treatment and monitor oxygen saturation, and if there is a local researcher who will act as the principal investigator for the locality |
| Participants - exclusion criteria |
Patients will be excluded from the trial if:
1. The responsible doctor considers the patient to have definite indications for or contraindications to oxygen treatment at a rate of 2 - 3 L/min. The decision will be left to the responsible clinician 2. The stroke is not the main clinical problem 3. He/she has another serious life-threatening illness likely to lead to death within the next few months. This group of patients is excluded because it is unlikely that they are going to derive any benefit from the trial treatment |
| Anticipated start date | 20/04/2008 |
| Anticipated end date | 01/11/2013 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at http://www.so2s.co.uk/ |
| Target number of participants | 6000 |
| Interventions |
Please note that as of 01/05/2008 the anticipated start date of this trial has been updated. The previous anticipated start date of this trial was 01/11/2007. Please also note that this trial is open to other countries. If your centre is interested in joining this trial, then please use the contact details below to discuss this matter.
Interventions: Treatment group 1: no routine oxygen supplementation during the first 72 hours after randomisation. Treatment group 2: oxygen per nasal cannula overnight (21:00 - 7:00) at a flow rate of 3 L/min (if baseline oxygen saturation is 93% or below) or at a flow rate of 2 L/min (if baseline oxygen saturation is greater than 93%) during the first three nights after randomisation. Treatment group 3: oxygen per nasal cannula continuously (day and night) at a flow rate of 3 L/min (if baseline oxygen saturation is 93% or below) or a flow rate of 2 L/min (if baseline oxygen saturation is greater than 93%) during the first 72 hours after randomisation. All patients will have regular observations of vital signs (blood pressure, heart rate, temperature and oxygen saturation) as per the local protocol of the stroke unit, but at least six-hourly. Treatment of any abnormal findings will be independent of trial allocation. Patients who require oxygen or changes in the dose of oxygen for clinical reasons at any time of the trial will be given the concentration of oxygen they require. |
| Primary outcome measure(s) | Modified Rankin Scale score at three months. |
| Secondary outcome measure(s) |
1. Secondary outcomes at one week:
1.1. Mortality 1.2. Number of patients with neurological deterioration (death or a greater than 4 point increase in the National Institutes of Health Stroke Scale [NIHSS]) 1.3. Deaths 1.4. Highest oxygen saturation during the first 72 hours 1.5. Lowest oxygen saturation during the first 72 hours 2. Secondary outcomes at three months: 2.1. Mortality 2.2. Percentage of patients living at home 2.3. Ability to perform activities of daily living (Barthel index) 2.4. Quality of life (EuroQuol) 2.5. Extended Activities of Daily Living (Nottingham EADL score) |
| Sources of funding |
1. North Staffordshire Combined Healthcare NHS Trust (UK)
2. Keele University (UK) 3. National Institute for Health Research (UK) - Research for Patient Benefit (RfPB) fund |
| Trial website | http://www.so2s.co.uk |
| Publications | |
| Contact name | Dr Christine Roffe |
| Address |
SOS STudy, Stroke Research, Medical Illustrations
Royal Infirmary Prince's Road Hartshill |
| City/town | Stoke-on-Trent |
| Zip/Postcode | ST4 7LN |
| Country | United Kingdom |
| Tel | +44 (0)1782 555875 |
| Fax | +44 (0)1782 555876 |
| Christine.roffe@northstaffs.nhs.uk | |
| Sponsor | North Staffordshire Combined Healthcare NHS Trust (UK) |
| Address |
c/o Roger N Bloor
Research and Development Eaves Lane, Bucknall |
| City/town | Stoke-on-Trent |
| Zip/Postcode | ST4 6QG |
| Country | United Kingdom |
| Tel | +44 (0)1782 275025 |
| Fax | +44 (0)1782 275047 |
| RogerN.Bloor@northstaffs.nhs.uk | |
| Sponsor website: | http://www.nsch-tr.wmids.nhs.uk/site/show_page.php3?page_id=1 |
| Date applied | 19/06/2007 |
| Last edited | 23/12/2008 |
| Date ISRCTN assigned | 10/07/2007 |
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| © 2010 ISRCTN unless otherwise stated. | |
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