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

Primary Purpose

Stroke, Acute

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Normobaric oxygen therapy

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Normobaric hyperoxia, r-tPA thrombolytic therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female with age from 18 to 85;
Acute ischemic stroke;
National Institutes of Health Stroke Scale (NIHSS) score of 4-25
mRS score less than 1 before onset of stroke symptom;
Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy;
Informed consent obtained

Exclusion Criteria:

Stroke or serious head trauma within the previous 3 months
Major surgery or severe trauma with in the preceding 3 months
Intracranial hemorrhage
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
Symptoms rapidly improving
Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
Arterial puncture at a noncompressible site within the previous 7 days
Seizure at the onset of stroke
Platelet count of less than 100,000 per cubic millimeter
Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
severe hepatic or renal dysfunction
active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
>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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NBO group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

levels of blood biomarkers

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)

Secondary Outcome Measures

Number of participants with adverse events that are related to treatment

Full Information

NCT ID

NCT02974283

First Posted

November 23, 2016

Last Updated

November 23, 2016

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02974283

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute

Keywords

Normobaric hyperoxia, r-tPA thrombolytic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NBO group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Normobaric oxygen therapy

Intervention Description

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:

Primary Outcome Measure Information:

Title

levels of blood biomarkers

Description

a serum marker for the evaluation of blood brain barrier damage based on animal experiments

Time Frame

7days

Title

Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

Time Frame

7days

Secondary Outcome Measure Information:

Title

Number of participants with adverse events that are related to treatment

Time Frame

7days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female with age from 18 to 85; Acute ischemic stroke; National Institutes of Health Stroke Scale (NIHSS) score of 4-25 mRS score less than 1 before onset of stroke symptom; Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy; Informed consent obtained Exclusion Criteria: Stroke or serious head trauma within the previous 3 months Major surgery or severe trauma with in the preceding 3 months Intracranial hemorrhage 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 Symptoms rapidly improving Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days Arterial puncture at a noncompressible site within the previous 7 days Seizure at the onset of stroke Platelet count of less than 100,000 per cubic millimeter Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere) severe hepatic or renal dysfunction active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; >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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xunming Ji, MD. Ph.D

Phone

+86-10-83198952

jixunming@vip.163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shuhai Shi, Ph.D.

Phone

+86-13-311145865

shishuhai100@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xunming Ji, MD. Ph.D

Organizational Affiliation

Capital Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

28931617

Citation

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.

Results Reference

derived

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

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