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

Capital Medical University

Status: Unknown

Conditions: Stroke, Acute

Treatments: Other: Normobaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02974283

NBO-2016

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

NBO group

Experimental group

Description:

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.

Treatment:

Other: Normobaric oxygen therapy

Control group

No Intervention group

Description:

The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy.