Clinical trial NCT03620370: Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke
Official title: The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke：A Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: Normobaric hyperoxia;
Acute ischemic stroke;
vascular recanalization;
Endovascular treatment;
reperfusion therapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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);

Primary outcomes:
measure: Cerebral infarct volume
timeFrame: 24-48h after randomization
Secondary outcomes:
measure: levels of blood biomarkers
timeFrame: baseline; 24 ± 6 hours, 7 ± 2 days
measure: modified Rankin Scale score (mRS)
timeFrame: 30 ± 5 days, 90 ± 10 days after randomization
measure: The good prognosis at 90 days assessed by modified Rankin scale (mRS).
timeFrame: 90 ± 10 days after randomization
measure: Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
timeFrame: 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]
measure: Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours
timeFrame: from baseline to 24 ± 6 hours
measure: Improvement of neurologic function after 24h
timeFrame: 24 ± 6 hours;
measure: Barthel Index (BI)
timeFrame: 30 ± 5 days, 90 ± 10 days after randomization
measure: Revascularization on 24-hour follow-up imaging
timeFrame: 24 (12 to 36) hours;
measure: 24-hour neurologic deterioration;
timeFrame: 24 ± 6 hours;
measure: any intracranial hemorrhage on 24-hour follow-up imaging
timeFrame: 24 (12 to 36) hours
measure: Symptomatic Intracerebral Hemorrhage
timeFrame: 24 (12 to 36) hours
measure: Mortality and Stroke recurrence
timeFrame: 90 ± 10 days after randomization
measure: Survival rates
timeFrame: 7 ± 2 days, 90 ± 10 days after randomization
measure: TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)
timeFrame: Time Frame: 4 hours ± 15 minutes
measure: The infarct volume on 24-hour follow-up imaging
timeFrame: 24 (12 to 36) hours;
measure: mRS4-6
timeFrame: 90 ± 10 days after randomization
Other outcomes:
measure: Subgroup analysis of infarct volume
timeFrame: 24-48h after randomization
Locations:
city: Beijin
country: China
facility: Xuanwu hospital;Capital Medical University
Study officials:
References:
citation: Li W, Qi Z, Ma Q, Ding J, Wu C, Song H, Yang Q, Duan J, Liu L, Kang H, Wu L, Ji K, Zhao W, Li C, Sun C, Li N, Fisher M, Ji X, Liu KJ. Normobaric Hyperoxia Combined With Endovascular Treatment for Patients With Acute Ischemic Stroke: A Randomized Controlled Clinical Trial. Neurology. 2022 Aug 23;99(8):e824-e834. doi: 10.1212/WNL.0000000000200775. Epub 2022 Jun 17.