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

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.

Conditions

• Acute Ischemic Stroke

Interventions

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.

Sponsors & Collaborators

• Beijing Friendship Hospital

  collaborator OTHER

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• People's Hospital of Beijing Daxing District

  collaborator OTHER

• Tianjin Huanhu Hospital

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Nanyang Central Hospital

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Zhumadian Central Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• Changsha Central Hospital

  collaborator OTHER

• Ji Xunming,MD,PhD

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-17

Primary Completion

2025-08-30

Completion

2025-10-30

Countries

• China

Study Locations