MPC Member Publications

This database contains a listing of population studies publications written by MPC Members. Anyone can add a publication by an MPC student, faculty, or staff member to this database; new citations will be reviewed and approved by MPC administrators.

Full Citation

Title: Normobaric Hyperoxia Combined with Endovascular Treatment in Patients with Acute Ischemic Stroke (OPENS-2) trial: protocol for a prospective, multicenter, randomized controlled study

Citation Type: Journal Article

Publication Year: 2023

ISSN: 1015-9770

DOI: 10.1159/000530004

Abstract: <p>Normobaric Hyperoxia (NBO) is a potentially promising stroke treatment strategy that could protect the ischemic penumbra and could be administered as an adjunct before vascular recanalization. However, the efficacy and safety of NBO have not been confirmed by randomized controlled trials.The study aims to assess the efficacy and safety of NBO for ischemic stroke due to large artery occlusion (LVO) of acute anterior circulation among patients who had endovascular treatment (EVT) and were randomized within 6h from symptom onset. Based on the data of the modified Rankin scale (mRS) score at 90 days from the normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke (OPENS: NCT03620370) trial, 284 patients will be included to achieve a 90% power by using Wilcoxon-Mann-Whitney (WMW) test and the proportional odds model to calculate the sample size. The study is a prospective, multicenter, blinded, randomized controlled trial. The NBO group is administered with mask oxygen therapy of 10L/min while the sham NBO group is with that of 1L/min. The primary outcome is the modified Rankin Scale (mRS) score at 90 days. Secondary endpoints include cerebral infarct volume at 24-48 hours, functional independence (mRS≤2) at 90 days, and improvement in neurological function at 24 hours. Safety outcomes include 90-day mortality, oxygen-related adverse events, and serious adverse events. This study will indicate whether NBO combined with EVT is superior to EVT alone for acute ischemic stroke caused by LVO in subjects randomized within 6h from symptom onset, and will provide some evidence for NBO intervention as an adjunct to thrombectomy for acute stroke.</p>

Url: https://karger.com/doi/10.1159/000530004

User Submitted?: No

Authors: Li, Weili; Wei, Ming; Liu, Lan; Lan, Jing; Wu, Chuanjie; Zhao, Wenbo; Li, Chuanhui; Chen, Jian; Hou, Chengbei; Ma, Qingfeng; Ji, Xunming

Periodical (Full): Cerebrovascular Diseases

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