Inhalation of oxygen at a normal pressure for penumbral rescue (rescue of not yet destroyed brain tissue) in patients with stroke due to a large vessel occlusion (ischemic stroke)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 456

Inclusion Criteria

• Age: = 18 years.
• Acute anterior circulation ischemic stroke due to a Large vessel occlusion (LVO) on CT or MR angiography, i.e. either terminal internal carotid artery (ICA) with M1/carotid-T, proximal M1, distal M1 (distal to perforating branches), or M2/3 segment(s).
• If TBY is likely to be conducted.
• NIHSS score of = 6 at screening.
• Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non-contrast CT or 5-10 on diffusion-weighted MRI (DWI-MRI)
• If recommended by the attending physician, CT or MR perfusion should be performed prior to NBHO
• NBHO can be initiated within 6 hours of symptom onset (witnessed) or symptom recognition (in case of wake-up or unknown onset stroke), and within 30 minutes after last image of baseline brain Imaging
• Pre-stroke mRS of 0 to 2
• Breastfeeding women must stop breastfeeding after randomization.
• Own written informed consent is not obtained prior to study inclusion but has to be gained as soon as possible. Patients who are able to give consent will be informed about trial participation orally and may consent to or decline participation. Patients unable to give consent will be enrolled through a deferred consent procedure (see Section 14.5 Subject Information and Informed Consent).
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 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 228

Exclusion Criteria

Neurological:
• TBY procedure initiated (groin puncture) prior to randomization.
• Rapid major improvement in neurological status prior to randomization.
• Any condition which precludes obtaining an accurate baseline NIHSS or outcome assessment (e.g. seizures, dementia, psychiatric or neuromuscular disease).
• Intracranial hemorrhage (except of cerebral microbleeds), intracranial tumor (except small meningioma), and/or intracranial arteriovenous malformation.
• Intracranial aneurysm or prior stent implantation in the vascular territory (upstream and downstream) affected by qualifying LVO.
• Suspected complete common carotid artery (CCA) occlusion, aortic dissection, cerebral vasculitis, septic embolism, or bacterial endocarditis.
• Acute bilateral stroke or stroke in multiple vascular territories (except of clinically silent micro-lesions).
Respiratory:
• Acute or chronic pulmonary disease or respiratory distress that may, in the clinical judgement of the investigator, interfere with the study intervention (e.g. acute pneumonia, COPD flare-up etc.)
• Prior to enrolment, > 2 L/min oxygen required to maintain peripheral oxygen saturation = 95%.
Other:
• Clinical suspicion of acute myocardial infarction (e.g. acute chest pain).
• Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol).
• Body temperature = 38.0°C at screening.
• History of severe allergy (more than rash) to contrast medium.
• Current treatment with nitrofurantoin or amiodaron, paraquat poisoning, or history of treatment with bleomycin.
• Pregnancy at screening, to be excluded (ß-HCG in serum or urine) in all women = 55 years except if surgically sterile; in women > 55 years pregnancy must be excluded only in case of increased probability e.g. due to in-vitro fertilization.
• Any co-existing or terminal disease (except qualifying stroke) with anticipated life expectancy of less than 6 months.
• Any pre-existing condition that may, in the clinical judgment of the investigator, not allow safe participation in the study (e.g. alcohol or substance abuse, co-existing disease).
• Participation in another interventional (drug or device) study within the last four weeks.
• Prior participation in the PROOF trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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