- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05965193
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke:Longterm Outcome (OPENS-3L)
March 26, 2024 updated by: Ji Xunming,MD,PhD
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
1230
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100069
- Recruiting
- Xuan Wu Hospital,Capital Medical University
-
Contact:
- Xunming Ji, MD. PhD
- Phone Number: 861013120136877
- Email: jixunming@vip.163.com
-
Contact:
- Hetao Bian, MD. PhD
- Phone Number: 18266806812
- Email: hetaobian@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg);
- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol);
- Oral warfarin anticoagulant with international normalized ratio(INR)>1.7 or PT>15 s;
- Heparin treatment was received within 24 h;
- Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
- Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
- Hereditary or acquired bleeding constitution;
- Onset with seizures;
- Severe liver and kidney dysfunction;
- Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen;
- Life expectancy < 1 year;
- Patients who could not complete the 90-day follow-up;
- Participation in other clinical trials within 3 months prior to screening;
- Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NBO group
Normobaric Hyperoxia combined with intravenous thrombolysis
|
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.
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.
|
Placebo Comparator: Control group
Nasal oxygen combined with intravenous thrombolysis
|
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.
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%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utility-weighted modified Rankin scale scores
Time Frame: 12 months±14 days after randomization
|
Utility-weighted modified Rankin scale scores
|
12 months±14 days after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excellent functional outcome
Time Frame: 12 months±14 days after randomization
|
Proportion of subjects with modified Rankin Scale (mRS) 0-1 at 12 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
|
12 months±14 days after randomization
|
Cerebral infarct volume
Time Frame: 24-48hours after randomization
|
The infarct volume of cerebral infarct is evaluated by MRI
|
24-48hours after randomization
|
modified Rankin Scale (mRS) score
Time Frame: 12 months±14 days after randomization
|
Ordinal distribution of mRS at 12 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
|
12 months±14 days after randomization
|
Good functional outcome
Time Frame: 12 months±14 days after randomization
|
Proportion of subjects with modified rankin scale (mRS) 0-2 at 12 months±14 days after randomization
|
12 months±14 days after randomization
|
Excellent functional outcome
Time Frame: 6 months±14 days after randomization
|
Proportion of subjects with modified Rankin Scale (mRS) 0-1 at 6 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
|
6 months±14 days after randomization
|
Good functional outcome
Time Frame: 6 months±14 days after randomization
|
Proportion of subjects with modified rankin scale (mRS) 0-2 at 6 months±14 days after randomization
|
6 months±14 days after randomization
|
modified Rankin Scale (mRS) score
Time Frame: 6 months±14 days after randomization
|
Ordinal distribution of mRS at 6 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
|
6 months±14 days after randomization
|
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Time Frame: 4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization
|
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
|
4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization
|
Barthel Index (BI)
Time Frame: 6 months±14 days,12 months±14 days after randomization
|
The BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
|
6 months±14 days,12 months±14 days after randomization
|
EuroQol five dimensions questionnaire(EQ-5D)
Time Frame: 6 months±14 days,12 months±14 days after randomization
|
The score ranges from 0 to 100, with higher scores indicating optimal health
|
6 months±14 days,12 months±14 days after randomization
|
Stroke-related mortality
Time Frame: 12 months±14 days after randomization
|
Safety endpoint; the proportion of stroke related deaths in each group
|
12 months±14 days after randomization
|
All-cause mortality
Time Frame: 12 months±14 days after randomization
|
Safety endpoint; the proportion of all patients who died in each group
|
12 months±14 days after randomization
|
Asymptomatic intracranial hemorrhage
Time Frame: 24 ± 6 hours after randomization
|
The incidence of asymptomatic intracranial hemorrhage at 24 ± 6 hours after randomization
|
24 ± 6 hours after randomization
|
PH2 intracranial hemorrhage
Time Frame: 24 ± 6 hours after randomization
|
The incidence of PH2 intracranial hemorrhage at 24 ± 6 hours after randomization (according to SITS standards)
|
24 ± 6 hours after randomization
|
Adverse events/serious adverse events
Time Frame: 24 ± 12 hours, 7 ± 2 days, 90± 7 days, 6 months±14 days,12 months±14 days after randomization
|
Safety endpoint; the proportion of adverse events/serious adverse events in each group
|
24 ± 12 hours, 7 ± 2 days, 90± 7 days, 6 months±14 days,12 months±14 days after randomization
|
Symptomatic intracranial hemorrhage
Time Frame: 24 ± 6 hours after randomization
|
Proportion of subjects with symptomatic intracranial hemorrhage at 24 ± 6 hours after randomization (defined by ECASSII and ECASS III)
|
24 ± 6 hours after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2023
Primary Completion (Estimated)
August 30, 2025
Study Completion (Estimated)
October 30, 2025
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
July 20, 2023
First Posted (Actual)
July 28, 2023
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Signs and Symptoms, Respiratory
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
- Hyperoxia
Other Study ID Numbers
- OPENS-3L
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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