The Efficacy and Safety of Normobaric Hyperoxia on Treatment Duration for Acute Ischemic Stroke Patients With Endovascular Treatment

Capital Medical University1 site in 1 country100 target enrollmentJune 20, 2022

ConditionsStroke, Acute Neuroprotection Endovascular Treatment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke, Acute
Sponsor: Capital Medical University
Enrollment: 100
Locations: 1
Primary Endpoint: Cerebral infarct volume
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.

Registry

clinicaltrials.gov

Start Date

June 20, 2022

End Date

September 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Capital Medical University

Responsible Party

Principal Investigator

Ji Xunming,MD,PhD

Principal Investigator

Capital Medical University

Eligibility Criteria

Inclusion Criteria

•Symptoms and signs were consistent with acute anterior circulation stroke,
•NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
•Met the indications for endovascular therapy;
•(Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
•The time from onset to randomization was within 24 hours;
•Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
•Patients and their families signed informed consent

Exclusion Criteria

•Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
•Seizures at stroke onset;
•Intracranial hemorrhage;
•Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
•Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR \> 3.0 or PTT \> 3 times normal;
•Platelet count of less than 100,000 per cubic millimeter;
•Severe hepatic or renal dysfunction;
•Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg)
•Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol) 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;

Outcomes

Primary Outcomes

Cerebral infarct volume

Time Frame: Within 72 hours after randomization

The infarct volume is evaluated by MRI or CT scan

Secondary Outcomes

Scores assessed by National Institutes of Health Stroke Scale(NIHSS)(24hours, 72hours, day7 after randomization)
neurological function improvement rate(Time Frame: 24 ± 6 hours)
Incidence of any intracranial hemorrhage(24± 12 hours hours after randomization)
Vital signs:heart rate: (times/min)(0 hours, 2 hours, 4 hours after randomization;)
all-cause death rate(90 ± 10 days after randomization)
Incidence of oxygen-related adverse events(24 ± 6 hours,)
blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc(24 ± 6 hours, 72 ± 24 hours)
Incidence of adverse events(90 ± 10 days after randomization)
Incidence of surgery-related complications(24± 12 hours hours after randomization)
Vital signs:blood pressure(mmHg)(0 hours, 2 hours, 4 hours after randomization;)
Vital signs:oxygen saturation (%)(0 hours, 2 hours, 4 hours after randomization;)
The proportion of good prognosis(90 ± 10 days after randomization)
modified Rankin Scale score (mRS) score(30 ± 7 days, 90 ± 10 days after randomization;)
Vascular recanalization rate(Time Frame: 4 hours ± 15 minutes)
Incidence of Symptomatic Intracerebral Hemorrhage(24± 12 hours hours after randomization)
stroke related death rate(90 ± 10 days after randomization;)
Vital signs:respiration(times/min)(0 hours, 2 hours, 4 hours after randomization;)
Incidence of neurologic deterioration;(24 ± 6 hours;)