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

Not Applicable

• Conditions: Stroke, Acute
• Interventions: Other: Normobaric oxygen therapy

• Registration Number: NCT02974283
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Study First Posted: 2016-11-28
• Last Update Posted: 2016-11-28
• Study Start: 2016-12
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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;

17. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBO group	Normobaric oxygen therapy	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.

Primary Outcome Measures

Name	Time	Method
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)	7days
levels of blood biomarkers	7days	a serum marker for the evaluation of blood brain barrier damage based on animal experiments

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events that are related to treatment	7days