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

November 23, 2016 updated by: Ji Xunming, Capital Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NBO group
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.
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:
NO_INTERVENTION: Control group
The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events that are related to treatment
Time Frame: 7days
7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Xunming Ji, MD. Ph.D, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 28, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBO-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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