E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary outcome measures are early changes in neurological deficit (difference in NIH Stroke Score from admission to one week) and death and disability (Mod. Rankin>3) at 6 months. |
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E.2.2 | Secondary objectives of the trial |
Secondary outcome measures are discharge destination (home, institution, still in hospital, death), activities of daily living (Barthel Index), extended activities of daily living ( Nottingham Extended Activities of Daily Living Index) and Quality of life (EuroQuol) at 6 months.
We will also report outcomes which stroke patients and their carers felt were important but which are not included in standard stroke outcome assessment tools such as sleep, memory and speech.
Predictors of death and disability (Mod. Rankin >3) or neurological deterioration (an increase of the NIHSS >4 from admission to week 1) will be examined using multiple logistic regression and all baseline clinical characteristics (including NIHSS subscores) as factors.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All adult patients with an acute stroke will be eligible to be considered for study participation. There are no definite guidelines for oxygen treatment after acute stroke, and there is uncertainty amongst stroke physicians about who should be given oxygen and for how long. The eligibility criteria for inclusion into the trial reflect this uncertainty, and allow for randomization of all acute stroke patients who do not have definite indications or definite contraindications for oxygen treatment.
Hence adult patients will be eligible for trial inclusion if: They were admitted with symptoms of an acute stroke within the preceding 24 hours, and in the doctor's opinion there is no clear indication for and no clear contraindication against oxygen treatment.
The diagnosis of stroke will be made by history and clinical examination and is at the discretion of the admitting doctor. It will based on the WHO criteria (rapidly developing clinical signs of focal or global disturbance of cerebral function, with symptoms lasting 24 hours or longer, or leading to death, with no apparent cause other than of vascular origin). Within the first 24 hours of symptom onset a definite distinction between a stroke and a transient ischaemic attack cannot be made. However, most patients who still have persistent symptoms after one hour will be confirmed to have a stroke. Since waiting for 24 hours for confirmation would unnecessarily delay treatment we omitted the time element from the definition of stroke for the purposes of trial inclusion.
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E.4 | Principal exclusion criteria |
Patients will be excluded from the trial if 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. This exclusion criterion has been chosen to ensure that all patients are treated according to best medical practice.
Potential indications for oxygen treatment could be: oxygen saturation on air <90%, hypoxia associated with acute left ventricular failure, severe pneumonia, pulmonary embolus, and chronic respiratory failure patients treated with long term oxygen at home.
Potential contraindications to fixed dose oxygen treatment could be type 2 respiratory failure and very severe hypoxia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measures are early changes in neurological deficit (difference in NIH Stroke Score from admission to one week) and death and disability (Mod. Rankin>3) at 6 months.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is when the last subject has completed follow-up. If complete follow up is not achieved it is 9 months after the last subject has been recruited. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |