Clinical trial NCT06801457: Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Official title: Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Stroke Acute
Keywords: Ischemic stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.

Detailed description: Stroke is a leading cause of death and disability globally, with acute ischemic stroke (AIS) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. However, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 days, remains under 50%.

Normobaric hyperoxia (NBO) emerges as a compelling option for cerebral protection. Its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. NBO's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. Its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 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;
* The time from stroke onset/last seen well to randomization is within 6 hours;
* Paramedic-obtained FAST-ED score \>= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
* No significant pre-stroke disability (pre-stroke mRS 0-1);
* Signed informed consent from the patient or the legally authorized representative (LAR).

Exclusion Criteria:

* Endotracheal intubation in the field (prior to consent);
* Respiratory rate \<= 10 or \>= 30 breaths per minute;
* Oxygen-dependence at baseline to maintain SaO2 \> 95%;
* Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
* Seizure at stroke onset;
* Exhibiting symptoms of vomiting, severe headache, or unconscious;
* Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
* Participating in another clinical trial, or completed participation within prior 30 days;
* Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
* Life expectancy \< 90 days due to comorbidities;
* Unlikely to complete the 90-day follow-up visit.

Primary outcomes:
measure: Level of disability at 90 days measured by modified Rankin scale (mRS) score
timeFrame: 90 days after randomization
Secondary outcomes:
measure: Functional independence at 90 days defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up
timeFrame: 90 days after randomization
measure: Excellent functional outcome at 90 days, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up
timeFrame: 90 days after randomization
measure: National Institutes of Health Stroke Scale (NIHSS) obtained obtained upon Endovascular Thrombectomy (EVT) site arrival
timeFrame: Day 0
measure: National Institutes of Health Stroke Scale (NIHSS) obtained at 24 hours
timeFrame: 24 hours after randomization
measure: ASPECTS on admission head CT
timeFrame: Day 0
measure: NCCT infarct volume at 24 hours in patients undergoing thrombolysis or EVT (standard of care)
timeFrame: 24 hours after randomization
measure: Proportion of patients with elevated troponin level upon EVT hospital arrival
timeFrame: Day 0
Other outcomes:
measure: Serious adverse events/Adverse events
timeFrame: Through study completion
measure: Symptomatic intracranial hemorrhage
timeFrame: Up to 36 hours after randomization
measure: Any intracranial hemorrhage
timeFrame: Up to 36 hours after randomization
measure: Early neurological deterioration
timeFrame: 24 hours after randomization
measure: Heart rate at the end of oxygen therapy
timeFrame: Day 0
measure: Respiratory rate at the end of oxygen therapy
timeFrame: Day 0
measure: Systolic blood pressure at the end of oxygen therapy
timeFrame: Day 0
measure: Diastolic blood pressure at the end of oxygen therapy
timeFrame: Day 0
measure: Oxygen saturation at the end of oxygen therapy
timeFrame: Day 0
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: