ArticleBrain circulation
Protocol for a prospective 1-year follow-up investigation on normobaric hyperoxia in conjunction with endovascular treatment for acute ischemic stroke (OPENS-2L) trial.
Article in Brain circulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05039697 (Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset：Longterm Outcome Analysis), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset：Longterm Outcome Analysis
Who cites it
2 citing papers in PubMed.
- Intermittent Hypoxia Maintains Neovascular Blood-Brain Barrier Integrity Via the HIF-1α/VEGFB Axis.Translational stroke research · 2026Article
- Multimodal Neuroprotection in Ischemic Stroke: Emerging Non-Pharmacological Interventions from Bench to Bedside.Brain sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOngoing research endeavors seek to identify neuroprotective drugs capable of mitigating brain cell necrosis and reperfusion injury by protecting the ischemic penumbra. Despite these efforts, the quest for effective neuroprotective agents remains elusive. Encouragingly, preliminary investigations, including basic experiments and single-center exploratory studies, have demonstrated the neuroprotective properties of normobaric hyperoxia (NBO). In pursuit of validating and expanding upon these findings, we have conducted a multicenter, prospective, randomized, controlled clinical trial known as OPENS-2. However, the OPENS-2 study only assessed outcomes at a 90-day endpoint, leaving uncertainties regarding the potential long-term benefits of NBO in stroke management. Thus, to address this gap in knowledge, we will initiate a long-term follow-up trial, OPENS-2L, building upon the foundation laid by the OPENS-2 study. MATERIALS AND
methodsThis prospective, randomized controlled clinical trial will enroll 280 patients at a 1:1 ratio. Patients will be randomly divided into the NBO combined with the endovascular treatment group, where they will receive 10 L/min of oxygen through a mask, or the control group, where they will receive 1 L/min of oxygen.
resultsThe primary endpoint of this study is the modified Rankin Scale (mRS) score at 1 year. Secondary endpoints include mRS 0-2, mRS 0-3, mRS 0-1 scores, Barthel index, and the EuroQol-5 Dimension score at 1 year. Safety endpoints encompass all-cause mortality at 1 year and the incidence of major vascular events.
conclusionIf this trial yields positive outcomes, it would furnish crucial evidence for guiding future neuroprotective research endeavors. Overall, the insights gained from this study hold the potential to illuminate the long-term benefits of NBO combined with endovascular treatment in improving stroke outcomes, thereby shaping the landscape of stroke management practices.
trial registrationClinicalTrials.gov NCT05039697.
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