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New treatment option for Ischemic Stroke
Official title Normobaric Oxygen in AIS Transferred for EVT
ClinicalTrials.gov ID: NCT06666764
What this study is testing
- What it's testing
- The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age at least 18 years old;
- Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder...
- No prior stroke in the last 3 months;
- Time from stroke onset (last seen well) to randomization is within 9 hours;
- (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis...
You likely can't join if
- Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV...
- Respiratory rate \ = 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
- Seizure at stroke onset;
- Exhibiting symptoms of vomiting, or severe headache, or unconscious;
- Rapidly improving neurological deficits or transient ischemic attack prior to consent;
See the full eligibility criteria
- Age at least 18 years old;
- Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
- No prior stroke in the last 3 months;
- Time from stroke onset (last seen well) to randomization is within 9 hours;
- (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA...
- NIHSS score 0 or 1 in the section of level of consciousness;
- No significant pre-stroke disability (pre-stroke mRS 0--1);
- ASPECTS at least 6 on non-contrast CT;
- Patient is planned for transfer to a EVT-capable hospital for EVT;
- Signed informed consent from the patient or the legally authorized representative (LAR).
- Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- Respiratory rate \ = 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
- Seizure at stroke onset;
- Exhibiting symptoms of vomiting, or severe headache, or unconscious;
- Rapidly improving neurological deficits or transient ischemic attack prior to consent;
- Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
- Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
- Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
- Life expectancy \< 90 days due to comorbidity;
- Unlikely to complete the 90-day follow-up;
- Participating in another clinical treatment trial, or completed participation within prior 30 days;
- Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
- Evidence of acute intracranial hemorrhage on CT/MRI;
- Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Ningde, Fujian, China
- Putian, Fujian, China
- Zhangzhou, Fujian, China
- Guangzhou, Guangdong, China
- Hezhou, Guangxi, China
- Cangzhou, Hebei, China
- Handan, Hebei, China
- Mudanjiang, Heilongjiang, China
- Luoyang, Henan, China
- Yima, Henan, China
- Zhoukou, Henan, China
- Zhoukou, Hennan, China
- Enshi, Hubei, China
- Huanggang, Hubei, China
- Lichuan, Hubei, China
- Dexing, Jiangxi, China
- Fuzhou, Jiangxi, China
- Jiujiang, Jiangxi, China
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Ningde, Fujian, China; Putian, Fujian, China; Zhangzhou, Fujian, China; Guangzhou, Guangdong, China and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.