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

NCT05965193 | Recruiting Phase 3

• 1 other identifier: OPENS-3L
• Study Type: interventional
• Target: 1,230
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Utility-weighted modified Rankin scale scores

  Utility-weighted modified Rankin scale scores

  12 months±14 days after randomization

Secondary Outcomes (16)

• Cerebral infarct volume

  24-48hours after randomization

• modified Rankin Scale (mRS) score

  12 months±14 days after randomization

• Good functional outcome

  12 months±14 days after randomization

• Excellent functional outcome

  6 months±14 days after randomization

• Good functional outcome

  6 months±14 days after randomization

Study Arms (2)

NBO group

EXPERIMENTAL

Normobaric Hyperoxia combined with intravenous thrombolysis

Device: Normobaric Hyperoxia; Drug: Intravenous thrombolysis(rt-PA)

Control group

PLACEBO COMPARATOR

Nasal oxygen combined with intravenous thrombolysis

Device: Nasal oxygen; Drug: Intravenous thrombolysis(rt-PA)

Interventions

Normobaric Hyperoxia DEVICE

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.

NBO group

Nasal oxygen DEVICE

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%.

Control group

Intravenous thrombolysis(rt-PA) DRUG

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.

Control group; NBO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years;
• The time from onset to randomization is within 4.5 hours of onset;
• The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
• Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
• Pre-stroke mRS score≤1 points;
• Informed consent from the patient or surrogate.

You may not qualify if:

• Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
• Past history of intracranial hemorrhage;
• Rapid neurological function improvement, NIHSS score less than 5 points;
• Presence of proximal arterial occlusion on computed tomography angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral arterial(MCA)-M1, and vertebrobasilar arteries);
• Massive anterior cerebral infarction identified by CT or MRI (ASPECT \< 6 or lesions larger than one third of the territory of the middle cerebral artery);
• Intended to proceed endovascular treatment;
• Pregnant women, or planning to become pregnant during the trial;
• A history of severe head trauma or stroke within 3 months;
• A history of intracranial or spinal surgery within 3 months;
• A history of gastrointestinal or urinary bleeding within 3 weeks;
• two weeks of major surgery;
• Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
• Active visceral bleeding;
• Intracranial tumors, large intracranial aneurysms;
• Aortic arch dissection was found;

Sponsors & Collaborators

• Ji Xunming,MD,PhD: lead
• Beijing Friendship Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Beijing Tongren Hospital: collaborator
• People's Hospital of Beijing Daxing District: collaborator
• Tianjin Huanhu Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Jining First People's Hospital: collaborator
• Linyi People's Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Rizhao People's Hospital: collaborator
• Zhumadian Central Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Affiliated Hospital of Nantong University: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• Changsha Central Hospital: collaborator

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 28, 2023
• Study Start: August 17, 2023
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CN (1)