Abstract Body: Title: Normobaric hyperoxia combined with intravenous thrombolysis for acute ischemic stroke (OPENS-3)
Trial Abbreviation: OPENS-3
Trial Registry: ClinicalTrials.gov: NCT05965687
Background:
Acute ischemic stroke (AIS) is a major cause of morbidity and mortality worldwide. Timely intravenous thrombolysis within 4.5 hours is essential, yet optimizing outcomes with adjunctive treatments remains a key research focus. Normobaric hyperoxia (NBO) has shown neuroprotective effects in animal models and efficacy in a single-center study, reducing brain injury and enhancing thrombolysis outcomes. The OPENS-3 trial was initiated as a multi-center study to further assess the combined effects of NBO and intravenous thrombolysis in AIS patients.
Objective:
To determine the efficacy and safety of normobaric hyperoxia combined with intravenous thrombolysis in patients with acute ischemic stroke.
Design:
The OPENS-3 trial is an ongoing, multi-center, interventional clinical trial with an estimated enrollment of 1,230 participants.
Population Studied:
Participants are adults aged 18 or older with a clinical diagnosis of acute ischemic stroke. Eligibility includes randomization within 4.5 hours of onset, a baseline NIHSS score between 5 and 25, and a pre-stroke mRS score of 1 or lower.
Interventions:
1.Normobaric hyperoxia Group: Patients receive standard intravenous thrombolysis and 100% oxygen at 10L/min via a sealed non-ventilating mask for 4 hours.
2.Control Group: Patients receive standard intravenous thrombolysis and 1L/min oxygen via nasal cannula for 4 hours.
Outcome Measures:
The primary outcome is the utility-weighted modified Rankin Scale (UW-mRS) at 3 months.
Safety outcomes include all-cause and stroke-related mortality at 90 days, and symptomatic intracranial hemorrhage at 24 hours ( ECASS II and III definitions).
Analysis:
Primary outcome analysis will employ intention-to-treat principles with adjustments for baseline prognostic variables. Secondary outcomes will be analyzed using appropriate statistical models to assess differences between two groups.
Trial Status:
OPENS-3 is actively recruiting participants and is in the data collection phase for baseline and follow-up assessments.
PI Name and Affiliation:
Xunming Ji, Capital Medical University, Beijing, China.
Sponsor: Capital Medical University.
Contact Information:
Hetao Bian, hetaobian@163.com,+8618266806812.
Trial E-mail:
hetaobian@163.com