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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02974283
• Other study ID #: NBO-2016
• Status: Not yet recruiting
• Phase: N/A
• First received: November 23, 2016
• Last updated: November 23, 2016
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2016
• Source: Capital Medical University
• Contact: Xunming Ji, MD. Ph.D
• Phone: +86-10-83198952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperoxia
• Stroke
• Stroke, Acute

Intervention

Other:
• 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:

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of blood biomarkers	a serum marker for the evaluation of blood brain barrier damage based on animal experiments	7days	Yes
Primary	Scores assessed by National Institutes of Health Stroke Scale(NIHSS)		7days	Yes
Secondary	Number of participants with adverse events that are related to treatment		7days	Yes