Clinical trial NCT05128422: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke
Official title: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Endovascular Treatment
Neuroprotection
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.


Eligibility criteria: Inclusion Criteria:

* age≥18;
* Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA;
* Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra;
* NIHSS score≥6;
* Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT;
* (Level of consciousness) NIHSS score of 0 or 1
* mRS score was 0-1 before stroke;
* 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);
* Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks;
* Other circumstances requiring emergency oxygen inhalation;

Primary outcomes:
measure: Early neurologic improvement (ENI) at 24 hours
timeFrame: 24 ± 12 hours
Secondary outcomes:
measure: National Institutes of Health Stroke Scale(NIHSS) Score
timeFrame: 4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization
measure: modified Rankin Scale score (mRS)
timeFrame: 90 ± 14 days after randomization
measure: Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours
timeFrame: 24 ± 12 hours after randomization
measure: Barthel Index (BI)
timeFrame: 90 ± 14 days after randomization
measure: Revascularization on 24-hour follow-up imaging
timeFrame: 24 ± 12 hours hours after randomization
measure: Early neurologic deterioration
timeFrame: 24 ± 12 hours after randomization
measure: Symptomatic Intracerebral Hemorrhage
timeFrame: 24± 12 hours hours after randomization
measure: Mortality
timeFrame: 90 ± 14 days after randomization
measure: Stroke recurrence
timeFrame: 90 ± 14 days，180 ± 30 days after randomization
measure: The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score
timeFrame: 90 ± 14 days after randomization
measure: Delta NIHSS
timeFrame: 24 ± 12 hours after randomization
measure: Percent change NIHSS
timeFrame: 24 ± 12 hours after randomization
measure: Cerebral infarct volume
timeFrame: 36 ± 12 hours after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Xunming Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: