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Normobaric Hyperoxia Stabilizing Ischemic Penumbra

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oxygen 100%
Sponsored by
Ji Xunming,MD,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Normobaric Hyperoxia, Acute ischemic stroke, penumbra

Eligibility Criteria

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

Inclusion criteria: Age≥18岁 The signs and symptoms are consistent with anterior circulation infarction, and baseline NIHSS score:6-20 Level of consciousness on admission:0-1 mRS score before stroke: 0-1 Patients who did not receive revascularization therapy The time from onset (finally normal) to randomization is less than 24h Patients who signed informed consent CTA or MRA confirmed internal carotid artery occlusion or M1/M2 segment occlusion of middle cerebral artery The low-perfusion area with Tmax>6s was larger than the core infarction, and the mismatch ratio was greater than or equal to 1.8. Exclusion Criteria: Evidence of rapid improvement in neurological function and NIHSS score <6, or spontaneous recanalization before randomization The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease) Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal) Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing It is necessary to inhale (>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2>95%) Anemia or polycythemia vera or other conditions needing emergency oxygen patients Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask Baseline blood glucose <2.78mmol/L or >22.2mmol/L Baseline platelet count <50×109/L Hereditary or acquired bleeding tendency, lack of coagulation factor, recent oral anticoagulant INR>3 or PPT more than 3 times Unstable vital signs (heart rate ≤50 beats/min or ≥120 beats/min, oxygen saturation ≤90%, R≥30 beats/min or ≤10 beats/min) Hypertension not controlled by medication: systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg Acute myocardial infarction suspected Pregnancy, Life expectancy <90 days Heart, liver and kidney failure Magnetic resonance contraindications Claustrophobia Allergic to contrast media Participating in other drug or device research

Sites / Locations

  • Xuanwu Hospital of Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NBO group

Control group

Arm Description

Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask.

Control group will be given nasal oxygen (2L/min for 4h). All other therapy measures are the same as experimental group.

Outcomes

Primary Outcome Measures

changing of penumbra volume from baseline
the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group

Secondary Outcome Measures

penumbra volume at 4h following randomizing
the absolute penumbra volume comparison between NBO and control group
volume of core infarction at 4h following randomizing
core infarction volume comparison between NBO and control group
volume of hypoperfusion region hypoperfusion at 4h following randomizing
the volume of hypoperfusion region hypoperfusion comparison between NBO and control group
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing
the comparison of NIHSS score between NBO and control group; NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome.
modified rankin scale (mRS) score at 90 days following randomizing
the mRS score comparison between NBO and control group; mRS score ranges from 0 to 5, and the higher score means a worse outcome.
Barthel Index at 90 days following randomizing
the comparison of Barthel Index between NBO and control group
EQ-5D index at 90 days following randomizing
the comparison of EQ-5D index between NBO and control group
BBB injured biomarkers at baseline and 24h following randomizing
the levels of BBB injured biomarkers comparison between NBO and control group
Cerebral oxygen concentration at baseline and 4h following randomizing
the levels of cerebral oxygen comparison between NBO and control group

Full Information

First Posted
March 6, 2023
Last Updated
April 17, 2023
Sponsor
Ji Xunming,MD,PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05781880
Brief Title
Normobaric Hyperoxia Stabilizing Ischemic Penumbra
Official Title
Efficiency and Safety Evaluation of Normobaric Hyperoxia Stabilizing the Penumbra in Patients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ji Xunming,MD,PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.
Detailed Description
All the enrolled patients were randomly assigned to NBO and control group. NBO group will be given 100% oxygen ( (10L/min for 4h) via a storage oxygen face mask and control group will be given oxygen using nasal oxygen(2L/min for 4h) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Normobaric Hyperoxia, Acute ischemic stroke, penumbra

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes indexes will be assessed by trained neurologists or neuroradiologists who are blinded to the research content or patient grouping.
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NBO group
Arm Type
Experimental
Arm Description
Normobaric hyperoxia (NBO) oxygen group will be given 100% oxgen (10L/min for 4h) via a face mask.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group will be given nasal oxygen (2L/min for 4h). All other therapy measures are the same as experimental group.
Intervention Type
Other
Intervention Name(s)
Oxygen 100%
Other Intervention Name(s)
Normobaric hyperoxia
Intervention Description
NBO therapy were given 100% oxygen via a face mask (10L/min for 4h)
Primary Outcome Measure Information:
Title
changing of penumbra volume from baseline
Description
the comparison of ratio of 4h following randomizing and baseline for penumbra volume between NBO and control group
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
penumbra volume at 4h following randomizing
Description
the absolute penumbra volume comparison between NBO and control group
Time Frame
Day 0
Title
volume of core infarction at 4h following randomizing
Description
core infarction volume comparison between NBO and control group
Time Frame
Day 0
Title
volume of hypoperfusion region hypoperfusion at 4h following randomizing
Description
the volume of hypoperfusion region hypoperfusion comparison between NBO and control group
Time Frame
Day 0
Title
National Institutes of Health Stroke Scale (NIHSS) score at 24h following randomizing
Description
the comparison of NIHSS score between NBO and control group; NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome.
Time Frame
Day 1
Title
modified rankin scale (mRS) score at 90 days following randomizing
Description
the mRS score comparison between NBO and control group; mRS score ranges from 0 to 5, and the higher score means a worse outcome.
Time Frame
Month 3
Title
Barthel Index at 90 days following randomizing
Description
the comparison of Barthel Index between NBO and control group
Time Frame
Month 3
Title
EQ-5D index at 90 days following randomizing
Description
the comparison of EQ-5D index between NBO and control group
Time Frame
Month 3
Title
BBB injured biomarkers at baseline and 24h following randomizing
Description
the levels of BBB injured biomarkers comparison between NBO and control group
Time Frame
Day 1
Title
Cerebral oxygen concentration at baseline and 4h following randomizing
Description
the levels of cerebral oxygen comparison between NBO and control group
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age≥18岁 The signs and symptoms are consistent with anterior circulation infarction, and baseline NIHSS score:6-20 Level of consciousness on admission:0-1 mRS score before stroke: 0-1 Patients who did not receive revascularization therapy The time from onset (finally normal) to randomization is less than 24h Patients who signed informed consent CTA or MRA confirmed internal carotid artery occlusion or M1/M2 segment occlusion of middle cerebral artery The low-perfusion area with Tmax>6s was larger than the core infarction, and the mismatch ratio was greater than or equal to 1.8. Exclusion Criteria: Evidence of rapid improvement in neurological function and NIHSS score <6, or spontaneous recanalization before randomization The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease) Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal) Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing It is necessary to inhale (>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2>95%) Anemia or polycythemia vera or other conditions needing emergency oxygen patients Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask Baseline blood glucose <2.78mmol/L or >22.2mmol/L Baseline platelet count <50×109/L Hereditary or acquired bleeding tendency, lack of coagulation factor, recent oral anticoagulant INR>3 or PPT more than 3 times Unstable vital signs (heart rate ≤50 beats/min or ≥120 beats/min, oxygen saturation ≤90%, R≥30 beats/min or ≤10 beats/min) Hypertension not controlled by medication: systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg Acute myocardial infarction suspected Pregnancy, Life expectancy <90 days Heart, liver and kidney failure Magnetic resonance contraindications Claustrophobia Allergic to contrast media Participating in other drug or device research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhifeng Qi, Ph.D
Phone
010-83199236
Email
qizhifeng@xwh.ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shuhua Yuan, Ph.D
Phone
15538260193
Email
750495168@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD
Organizational Affiliation
Xuanwu Hospital of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhua Yuan, Ph.D

12. IPD Sharing Statement

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Normobaric Hyperoxia Stabilizing Ischemic Penumbra

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