Protective Effects of Normobaric Hyperoxia on Blood Brain Barrier in Patients With Acute Ischemic Stroke
NCT ID: NCT02974283
Last Updated: 2016-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-12-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NBO group
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.
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 within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. .
Other Names:
Control group
The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy.
No interventions assigned to this group
Interventions
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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 within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. .
Other Names:
Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke;
3. National Institutes of Health Stroke Scale (NIHSS) score of 4-25
4. mRS score less than 1 before onset of stroke symptom;
5. Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy;
6. Informed consent obtained
Exclusion Criteria
2. Major surgery or severe trauma with in the preceding 3 months
3. Intracranial hemorrhage
4. 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
5. Symptoms rapidly improving
6. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
8. Arterial puncture at a noncompressible site within the previous 7 days
9. Seizure at the onset of stroke
10. Platelet count of less than 100,000 per cubic millimeter
11. Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
12. Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
13. CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
14. severe hepatic or renal dysfunction
15. active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
16. \>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
18 Years
85 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming
professor
Principal Investigators
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Xunming Ji, MD. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University
Central Contacts
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References
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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.
Other Identifiers
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NBO-2016
Identifier Type: -
Identifier Source: org_study_id