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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,230

Participants

Timeline

Start Date

August 17, 2023

Primary Completion Date

August 30, 2025

Study Completion Date

October 30, 2025

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.

Trial Locations (1)

100069

RECRUITING

Xuan Wu Hospital,Capital Medical University, Beijing

All Listed Sponsors
collaborator

Beijing Friendship Hospital

OTHER

collaborator

Beijing Shijitan Hospital, Capital Medical University

OTHER

collaborator

Beijing Tongren Hospital

OTHER

collaborator

People's Hospital of Beijing Daxing District

OTHER

collaborator

Tianjin Huanhu Hospital

OTHER

collaborator

Guizhou Provincial People's Hospital

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

collaborator

The First Affiliated Hospital of Soochow University

OTHER

collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

collaborator

Jining First People's Hospital

OTHER

collaborator

Linyi People's Hospital

OTHER

collaborator

Nanyang Central Hospital

OTHER

collaborator

Rizhao People's Hospital

OTHER

collaborator

Zhumadian Central Hospital

OTHER

collaborator

Second Affiliated Hospital of Nanchang University

OTHER

collaborator

Affiliated Hospital of Nantong University

OTHER

collaborator

The Second Hospital of Anhui Medical University

OTHER

collaborator

Changsha Central Hospital

OTHER

lead

Ji Xunming,MD,PhD

OTHER