NCT05965193

Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,230 (estimated)
• Sponsor: Ji Xunming,MD,PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.

Detailed description

In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators aimed to determine the long-term effect of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Normobaric Hyperoxia	Within 4.5 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
DEVICE	Nasal oxygen	For nasal oxygen group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%.
DRUG	Intravenous thrombolysis(rt-PA)	10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg.

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-08-30
• Completion: 2025-10-30
• First posted: 2023-07-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: China