Stroke, Acute
Conditions
Keywords
Normobaric hyperoxia, r-tPA thrombolytic therapy
Brief summary
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.
Interventions
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:
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female with age from 18 to 85; 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
1. Stroke or serious head trauma within the previous 3 months 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| levels of blood biomarkers | 7days | a serum marker for the evaluation of blood brain barrier damage based on animal experiments |
| Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | 7days | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events that are related to treatment | 7days |
Contacts
Primary ContactXunming Ji, MD. Ph.D
Backup ContactShuhai Shi, Ph.D.
Outcome results
None listed