Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

Stroke, Acute Clinical Trial

Official title:

The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke：A Randomized, Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620370
• Other study ID #: OPENS-1
• Status: Completed
• Phase: N/A
• Start date: August 12, 2018
• Est. completion date: October 19, 2019

Study information

• Verified date: July 2020
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 19, 2019
• Est. primary completion date: July 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?

• 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);

Related Conditions & MeSH terms

• Hyperoxia
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

Drug:
• Normobaric oxygen therapy
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.

Locations

Country	Name	City	State
China	Xuanwu hospital;Capital Medical University	Beijin

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analysis of infarct volume	Stratify according to different risk factors:ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume	24-48h after randomization
Primary	Cerebral infarct volume	Infarct volume is evaluated mainly through brain MRI(DWI)	24-48h after randomization
Secondary	levels of blood biomarkers	Biomarkers for evaluation of BBB damage and brain injury:NSE?S100B?occludin? claudin-5?MMP-9	baseline; 24 ± 6 hours, 7 ± 2 days
Secondary	modified Rankin Scale score (mRS)	secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)	30 ± 5 days, 90 ± 10 days after randomization
Secondary	The good prognosis at 90 days assessed by modified Rankin scale (mRS).	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;	90 ± 10 days after randomization
Secondary	Scores assessed by National Institutes of Health Stroke Scale(NIHSS)	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	2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]
Secondary	Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 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)	from baseline to 24 ± 6 hours
Secondary	Improvement of neurologic function after 24h	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)	24 ± 6 hours;
Secondary	Barthel Index (BI)	secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);	30 ± 5 days, 90 ± 10 days after randomization
Secondary	Revascularization on 24-hour follow-up imaging	secondary imaging efficacy endpoint;	24 (12 to 36) hours;
Secondary	24-hour neurologic deterioration;	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;	24 ± 6 hours;
Secondary	any intracranial hemorrhage on 24-hour follow-up imaging	imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification	24 (12 to 36) hours
Secondary	Symptomatic Intracerebral Hemorrhage	imaging safety endpoints;Deterioration in NIHSS score of =4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification	24 (12 to 36) hours
Secondary	Mortality and Stroke recurrence	clinical safety endpoint;	90 ± 10 days after randomization
Secondary	Survival rates	secondary clinical efficacy endpoint;	7 ± 2 days, 90 ± 10 days after randomization
Secondary	TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)	secondary imaging efficacy endpoint;	Time Frame: 4 hours ± 15 minutes
Secondary	The infarct volume on 24-hour follow-up imaging	The infarct volume of cerebral infarct is evaluated by cranial CT;	24 (12 to 36) hours;
Secondary	mRS4-6	secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)	90 ± 10 days after randomization