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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBO group | Experimental | 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. |
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| Control group | No Intervention | The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normobaric oxygen therapy | Other | 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: |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events that are related to treatment | 7days |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD. Ph.D | Contact | +86-10-83198952 | jixunming@vip.163.com | |
| Shuhai Shi, Ph.D. | Contact | +86-13-311145865 | shishuhai100@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD. Ph.D | Capital Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28931617 | Derived | Shi S, Qi Z, Ma Q, Pan R, Timmins GS, Zhao Y, Shi W, Zhang Y, Ji X, Liu KJ. Normobaric Hyperoxia Reduces Blood Occludin Fragments in Rats and Patients With Acute Ischemic Stroke. Stroke. 2017 Oct;48(10):2848-2854. doi: 10.1161/STROKEAHA.117.017713. Epub 2017 Sep 20. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |