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Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

Primary Purpose

Stroke, Acute

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Normobaric oxygen therapy

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Normobaric hyperoxia;, Acute ischemic stroke;, vascular recanalization;, Endovascular treatment;, reperfusion therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, age≥18 and ≤ 80;
Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA;
Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra;
NIHSS score≥6分
Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT;
Informed consent obtained;

Exclusion Criteria:

Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
Seizures at stroke onset;
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;
Platelet count of less than 100,000 per cubic millimeter;
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;
medically unstable;
inability to obtain informed consent;
Life expectancy<90 days;
Pregnant or breast-feeding women;
Unwilling to be followed up or poor compliance for treatment;
Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
Evidence of intracranial tumor;
Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);

Sites / Locations

Xuanwu hospital;Capital Medical University

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 in the pre-hospital or emergency room as soon as possible (within 1 hours) after diagnosis of ischemic stroke and last for 4 hours. All participant will receive mechanical thrombectomy and a standard clinical therapy.

The participants receive mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy.

Outcomes

Primary Outcome Measures

Cerebral infarct volume

Infarct volume is evaluated mainly through brain MRI(DWI)

Secondary Outcome Measures

levels of blood biomarkers

Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9

modified Rankin Scale score (mRS)

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

The good prognosis at 90 days assessed by modified Rankin scale (mRS).

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2;

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

secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits

Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

Improvement of neurologic function after 24h

NIHSS score decreased by more than 4 points or NIHSS score was 0;secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

Barthel Index (BI)

secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

Revascularization on 24-hour follow-up imaging

secondary imaging efficacy endpoint;

24-hour neurologic deterioration;

NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;

any intracranial hemorrhage on 24-hour follow-up imaging

imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification

Symptomatic Intracerebral Hemorrhage

imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification

Mortality and Stroke recurrence

clinical safety endpoint;

Survival rates

secondary clinical efficacy endpoint;

TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)

secondary imaging efficacy endpoint;

The infarct volume on 24-hour follow-up imaging

The infarct volume of cerebral infarct is evaluated by cranial CT;

mRS4-6

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

Full Information

NCT ID

NCT03620370

First Posted

August 3, 2018

Last Updated

July 18, 2023

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03620370

Brief Title

Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

Official Title

The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke：A Randomized, Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

August 12, 2018 (Actual)

Primary Completion Date

July 21, 2019 (Actual)

Study Completion Date

October 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.

6. Conditions and Keywords

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

Stroke, Acute

Keywords

Normobaric hyperoxia;, Acute ischemic stroke;, vascular recanalization;, Endovascular treatment;, reperfusion therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

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 mechanical thrombectomy therapy after diagnosed ischemic. All participants receive a standard clinical therapy.

Intervention Type

Drug

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 in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.

Primary Outcome Measure Information:

Title

Cerebral infarct volume

Description

Infarct volume is evaluated mainly through brain MRI(DWI)

Time Frame

24-48h after randomization

Secondary Outcome Measure Information:

Title

levels of blood biomarkers

Description

Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9

Time Frame

baseline; 24 ± 6 hours, 7 ± 2 days

Title

modified Rankin Scale score (mRS)

Description

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

Time Frame

30 ± 5 days, 90 ± 10 days after randomization

Title

The good prognosis at 90 days assessed by modified Rankin scale (mRS).

Description

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2;

Time Frame

90 ± 10 days after randomization

Title

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

Description

secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits

Time Frame

2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]

Title

Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

Description

secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

Time Frame

from baseline to 24 ± 6 hours

Title

Improvement of neurologic function after 24h

Description

Time Frame

24 ± 6 hours;

Title

Barthel Index (BI)

Description

secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

Time Frame

30 ± 5 days, 90 ± 10 days after randomization

Title

Revascularization on 24-hour follow-up imaging

Description

secondary imaging efficacy endpoint;

Time Frame

24 (12 to 36) hours;

Title

24-hour neurologic deterioration;

Description

NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;

Time Frame

24 ± 6 hours;

Title

any intracranial hemorrhage on 24-hour follow-up imaging

Description

imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification

Time Frame

24 (12 to 36) hours

Title

Symptomatic Intracerebral Hemorrhage

Description

imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification

Time Frame

24 (12 to 36) hours

Title

Mortality and Stroke recurrence

Description

clinical safety endpoint;

Time Frame

90 ± 10 days after randomization

Title

Survival rates

Description

secondary clinical efficacy endpoint;

Time Frame

7 ± 2 days, 90 ± 10 days after randomization

Title

TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)

Description

secondary imaging efficacy endpoint;

Time Frame

Time Frame: 4 hours ± 15 minutes

Title

The infarct volume on 24-hour follow-up imaging

Description

The infarct volume of cerebral infarct is evaluated by cranial CT;

Time Frame

24 (12 to 36) hours;

Title

mRS4-6

Description

secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

Time Frame

90 ± 10 days after randomization

Other Pre-specified Outcome Measures:

Title

Subgroup analysis of infarct volume

Description

Stratify according to different risk factors：ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume

Time Frame

24-48h after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age≥18 and ≤ 80; Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA; Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization; Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra; NIHSS score≥6分 Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT; Informed consent obtained; Exclusion Criteria: Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization; Seizures at stroke onset; 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; Platelet count of less than 100,000 per cubic millimeter; 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; medically unstable; inability to obtain informed consent; Life expectancy<90 days; Pregnant or breast-feeding women; Unwilling to be followed up or poor compliance for treatment; Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial; Evidence of intracranial tumor; Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);

Facility Information:

Facility Name

Xuanwu hospital;Capital Medical University

City

Beijin

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35715198

Citation

Li W, Qi Z, Ma Q, Ding J, Wu C, Song H, Yang Q, Duan J, Liu L, Kang H, Wu L, Ji K, Zhao W, Li C, Sun C, Li N, Fisher M, Ji X, Liu KJ. Normobaric Hyperoxia Combined With Endovascular Treatment for Patients With Acute Ischemic Stroke: A Randomized Controlled Clinical Trial. Neurology. 2022 Aug 23;99(8):e824-e834. doi: 10.1212/WNL.0000000000200775. Epub 2022 Jun 17. Erratum In: Neurology. 2023 Apr 25;100(17):844.

Results Reference

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Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

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