Protective Effects of Normobaric Hyperoxia on Blood Brain Barrier in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to find out a serum marker for the evaluation of blood brain barrier damage based on animal experiments and investigate the effect of NBO（Normobaric hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA thrombolytic therapy.

Official Title
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The Effect of Normobaric Hyperoxia on Blood Brain Barrier in AIS Patients Based on a Blood Marker for the Evaluation of Blood Brain Barrier Damage From Animal Experiments

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: Normobaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female with age from 18 to 85; Acute ischemic stroke; National Institutes of Health Stroke Scale (NIHSS) score of 4-25 mRS score less than 1 before onset of stroke symptom; Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy; Informed consent obtained Exclusion Criteria: Stroke or serious head trauma within the previous 3 months Major surgery or severe trauma with in the preceding 3 months 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 Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days Arterial puncture at a noncompressible site within the previous 7 days Seizure at the onset of stroke Platelet count of less than 100,000 per cubic millimeter Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds 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; 17 medically unstable; 18. inability to obtain informed consent. 19. Life expectancy<1 years 20. Pregnant or breast-feeding women 21. Unwilling to be followed up or poor compliance for treatment 22. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBO group<br>Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start within 1 hours after diagnosis of ischemic stroke and last for 4hours. All participants will receive r-tPA thrombolytic therapy and a standard clinical therapy. | Other: Normobaric oxygen therapy<br>* 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 within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. . Other Names:<br>|
| No Intervention: Control group<br>The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of blood biomarkers | a serum marker for the evaluation of blood brain barrier damage based on animal experiments | 7days | 
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) |  | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events that are related to treatment |  | 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normobaric hyperoxia, r-tPA thrombolytic therapy