Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Stroke, Acute
• Interventions: Drug: Normobaric oxygen therapy

• Registration Number: NCT03620370
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-08
• Study Start: 2018-08-12
• Primary Completion: 2019-07-21
• Study Completion: 2019-10-19
• Status Verified: 2020-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBO group	Normobaric oxygen therapy	Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.

Primary Outcome Measures

Name	Time	Method
Cerebral infarct volume	24-48h after randomization	Infarct volume is evaluated mainly through brain MRI(DWI)

Secondary Outcome Measures

Name	Time	Method
Revascularization on 24-hour follow-up imaging	24 (12 to 36) hours;	secondary imaging efficacy endpoint;
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
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
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
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
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;
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)
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)
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;
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);
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;
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)

Trial Locations

Locations (1)

Xuanwu hospital;Capital Medical University; 🇨🇳 Beijin, China