Acute Ischemic Stroke
Conditions
Keywords
HBO, acute ischemic stroke, endovascular treatment
Brief summary
1. The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment 2. The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment? 3. Participants will: receive HBO (1.6 Atmosphere Absolute，1.6ATA)，Once a day, for 1 hour each time, for 5 days a week (it can be non-consecutive days), the total course of treatment is 10 times. undergo three scheduled face to face or telephone follow-up assessments during the 12-month period following HBO.
Interventions
OTHERHyperbaric Oxygen Therapy
1.6 atmosphere absolute (1.6 ATA), HBO treatment administrated via mask or hood, one 60 minutes session, once daily, 5 days a week (can be non consecutive days), with a total of 10 sessions.
OTHERConventional therapy group
Conventional therapy
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 35-75 years * The symptoms and signs are consistent with acute anterior circulation ischemic stroke. The immediate postoperative angiographic recanalization grade was ≥ 2b. * Neurological deficit score at the time of enrollment: 5 ≤ NIHSS ≤ 15 points * Consciousness status (NIHSS 1a-1b items): 0-1 point * Pre-stroke functional status (mRS score): 0-1 * Time from surgery to randomization grouping: ≤ 72 hours * Patient or legal representative who signed the informed consent form * Preoperative CT angiography or magnetic resonance angiography confirmed large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that was consistent with the symptoms and signs; And the area supplied by the middle cerebral artery in the brain is less than 1/3. * A lberta S troke P rogram E arly C T S core ≥ 6
Exclusion criteria
* Subjects with HBO contraindications or intolerance * Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation * Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis * Expected lifespan \< 90 days * Severe heart, liver and kidneys failure * Pregnancy * Hereditary or acquired bleeding tendency, deficiency of coagulation factors, recent use of oral anticoagulants with an international normalized ratio (INR) \> 3 or activated partial thromboplastin time (APTT) exceeding the normal value by more than 3 times * Baseline platelet count \< 50×10 9/L * Baseline blood glucose is less than 2.78 mmol/L or greater than 22.2 mmol/L. * Unstable vital signs (heart rate ≤ 50 beats/min or ≥ 120 beats/min, oxygen saturation ≤ 90%, respiration ≥ 30 breaths/min or ≤ 10 breaths/min); * Hypertension that cannot be controlled by medication: Systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg; * Suspected of having acute myocardial infarction; * Currently involving in the research of other projects related to drugs or medical devices. * CT or MRI scans revealed intracranial tumors (except for cerebellar meningiomas) and intracranial arteriovenous malformations. * Based on the medical history and CT or MRI findings, a diagnosis of internal carotid artery dissection or aortic dissection is suspected; * Based on the medical history and CT or MRI findings, cerebral vasculitis is suspected. * Based on the clinical evidence of multiple vascular regions being occluded (either in the bilateral anterior circulation or anterior/posterior circulation) or bilateral infarction or multi-region infarction as detected by CT angiography or magnetic resonance angiography; * CT or magnetic resonance imaging shows a significant midline shift effect (\> 0.5 cm); * CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days | Day 90 (±7) post-randomization | Modified Rankin Scale (mRS) is defined as the gold standard for measuring global functional outcomes after stroke: 0-1 indicating functional independence, 0-2 favorable prognosis, defining functional independence, 4-5 Severely disabled, 6 death. Higher mRS scores indicate worse prognosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core infarction volume on Diffusion-Weighted Imaging | Day 10 (±1）post-randomization | The effectiveness of HBO for patients with acute ischemic stroke was evaluated based on the core cerebral infarction volume. |
| National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)] | Day 10(±1) NIHSS score post-randomization | The effectiveness of HBO therapy in patients with acute ischemic stroke undergoing endovascular treatment was evaluated based on the improvement rate of NIHSS score day 10 post-randomization. |
| mRS score [ (0, Normal)-(6, worst)] | Day 10 (±1）post-randomization; Day 30(±3) post-randomization; Day 180(±14) post-randomization; Day 360(±30) post-randomization. | To assess the effectiveness of HBO treament for ischemic stroke using mRS score on day 10, 30, 90 and 360 post-randomization |
| Distribution of mRS score [(0, normal)-6(worst)] | Day 90 (±7) post-randomization | mRS (0-1): the proportion of functional independence; mRS (0-2): the proportion of good prognosis; mRS (4-6) : the proportion of severe disability. |
| Bartherl index (BI)[(0, worst)-(100, normal)] | Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization | Functional independence was assessed using the BI |
| EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)] | Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization | Health-related quality of life was measured using EQ-5D. |
| Stroke recurrence rate | Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization | New symptoms persisting for \> 24 hours and new lension on the DWI. |
Countries
China
Contacts
CONTACTShuyuan Yuan
Outcome results
None listed