The Stroke Oxygen Study. A randomised controlled study of the benefits and risks of routine oxygen treatment after acute stroke - Stroke Oxygen Study

• Conditions: Acute Stroke

• Registration Number: EUCTR2006-003479-11-GB
• Lead Sponsor: orth Staffordshire Combined Healthcare Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 6000

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified