Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)
NCT ID: NCT05965687
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1230 participants
INTERVENTIONAL
2023-08-17
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Nasal oxygen combined with intravenous thrombolysis
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%.
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.
NBO group
Normobaric Hyperoxia combined with intravenous thrombolysis
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.
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.
Interventions
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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.
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%.
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.
Eligibility Criteria
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Inclusion Criteria
2. The time from onset to randomization is within 4.5 hours of onset;
3. The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
4. Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
5. Pre-stroke mRS score≤1 points;
6. Informed consent from the patient or surrogate.
Exclusion Criteria
2. Past history of intracranial hemorrhage;
3. Rapid neurological function improvement, NIHSS score less than 5 points;
4. Presence of proximal arterial occlusion on computed tomographic angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral artery(MCA)-M1, and vertebrobasilar arteries);
5. 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);
6. Intended to proceed endovascular treatment;
7. Pregnant women, or planning to become pregnant during the trial;
8. A history of severe head trauma or stroke within 3 months;
9. A history of intracranial or spinal surgery within 3 months;
10. A history of gastrointestinal or urinary bleeding within 3 weeks;
11. two weeks of major surgery;
12. Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
13. Active visceral bleeding;
14. Intracranial tumors, large intracranial aneurysms;
15. Aortic arch dissection was found;
16. Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg);
17. Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol);
18. Oral warfarin anticoagulant with international normalized ratio(INR)\>1.7 or prothrombin time(PT)\>15 s;
19. Heparin treatment was received within 24 h;
20. Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
21. Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
22. Hereditary or acquired bleeding constitution;
23. Onset with seizures;
24. Severe liver and kidney dysfunction;
25. Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
26. Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
27. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen;
28. Life expectancy \< 1 year;
29. Patients who could not complete the 90-day follow-up;
30. Participation in other clinical trials within 3 months prior to screening;
31. Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
18 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Beijing Shijitan Hospital, Capital Medical University
OTHER
Beijing Tongren Hospital
OTHER
People's Hospital of Beijing Daxing District
OTHER
Tianjin Huanhu Hospital
OTHER
Guizhou Provincial People's Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
The First Affiliated Hospital of Soochow University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Jining First People's Hospital
OTHER
Linyi People's Hospital
OTHER
Nanyang Central Hospital
OTHER
Rizhao People's Hospital
OTHER
Zhumadian Central Hospital
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Affiliated Hospital of Nantong University
OTHER
The Second Hospital of Anhui Medical University
OTHER
Changsha Central Hospital
OTHER
Jiujiang University Affiliated Hospital
OTHER_GOV
Liaocheng People's Hospital
OTHER
Chengde Central Hospital
OTHER_GOV
The First Affiliated Hospital of Anhui Medical University
OTHER
Jiangxi Provincial People's Hopital
OTHER
Ji Xunming,MD,PhD
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor
Locations
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Xuan Wu Hospital，Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OPENS-3
Identifier Type: -
Identifier Source: org_study_id
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