Stroke, Acute
Conditions
Keywords
Normobaric hyperoxia;, Acute ischemic stroke;, vascular recanalization;, Endovascular treatment;, reperfusion therapy
Brief summary
NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.
Interventions
In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age≥18 and ≤ 80; * Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA; * Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization; * Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra; * NIHSS score≥6分 * Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT; * Informed consent obtained;
Exclusion criteria
* Rapid improvement in neurological status to an NIHSS \< 6 or evidence of vessel recanalization prior to randomization; * Seizures at stroke onset; * Intracranial hemorrhage; * Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits; * Symptoms rapidly improving; * Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; * Platelet count of less than 100,000 per cubic millimeter; * CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere); * severe hepatic or renal dysfunction; * active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; * \>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)﹥95% as per current stroke management guidelines; * medically unstable; * inability to obtain informed consent; * Life expectancy\<90 days; * Pregnant or breast-feeding women; * Unwilling to be followed up or poor compliance for treatment; * Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial; * Evidence of intracranial tumor; * Baseline blood glucose of \< 50 mg/dL (2.78 mmol) or \> 400 mg/dL (22.20 mmol);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral infarct volume | 24-48h after randomization | Infarct volume is evaluated mainly through brain MRI(DWI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| levels of blood biomarkers | baseline; 24 ± 6 hours, 7 ± 2 days | Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9 |
| modified Rankin Scale score (mRS) | 30 ± 5 days, 90 ± 10 days after randomization | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death) |
| The good prognosis at 90 days assessed by modified Rankin scale (mRS). | 90 ± 10 days after randomization | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2; |
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ] | secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits |
| Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours | from baseline to 24 ± 6 hours | secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits) |
| Improvement of neurologic function after 24h | 24 ± 6 hours; | NIHSS score decreased by more than 4 points or NIHSS score was 0;secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits) |
| Barthel Index (BI) | 30 ± 5 days, 90 ± 10 days after randomization | secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis); |
| Revascularization on 24-hour follow-up imaging | 24 (12 to 36) hours; | secondary imaging efficacy endpoint; |
| any intracranial hemorrhage on 24-hour follow-up imaging | 24 (12 to 36) hours | imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification |
| Symptomatic Intracerebral Hemorrhage | 24 (12 to 36) hours | imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification |
| Mortality and Stroke recurrence | 90 ± 10 days after randomization | clinical safety endpoint; |
| Survival rates | 7 ± 2 days, 90 ± 10 days after randomization | secondary clinical efficacy endpoint; |
| TICI (Thrombolysis in Cerebral Infarction perfusion scale grade) | Time Frame: 4 hours ± 15 minutes | secondary imaging efficacy endpoint; |
| The infarct volume on 24-hour follow-up imaging | 24 (12 to 36) hours; | The infarct volume of cerebral infarct is evaluated by cranial CT; |
| mRS4-6 | 90 ± 10 days after randomization | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death) |
| 24-hour neurologic deterioration; | 24 ± 6 hours; | NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint; |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis of infarct volume | 24-48h after randomization | Stratify according to different risk factors：ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume |
Countries
China
Outcome results
None listed