Acute Ischemic Stroke From Large Vessel Occlusion
Conditions
Keywords
Hyperbaric Oxygen Therapy, Thrombectomy, Acute ischemic stroke, Large vessel occlusion
Brief summary
The purpose of this RCT trial is to evaluate whether the sequential hyperbaric oxygen therapy can improve the 90-day functional outcome in patients with acute large vessel occlusion ischemic stroke after endovascular treatment.
Detailed description
This is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial with a 1:1 ratio, comparing the effect of hyperbaric oxygen therapy plus standard medical treatment versus standard medical treatment alone after endovascular treatment in patients with acute large vessel occlusion ischemic stroke. The primary outcome is modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization.
Interventions
OTHERHyperbaric oxygen therapy plus standard medical treatment
The first treatment was initiated within 24 hours after enrollment. The treatment plan is: in a medical multi-person air pressurized chamber, the treatment pressure is 0.2 MPa, the pressurization time is 30 minutes, the mask inhales 100% oxygen for 60 minutes, and the decompression time is 30 minutes. Once a day, once on the 1st, 2nd, and 3rd days after enrollment (i.e., within the 24-hour, 48-hour, and 72-hour time window), a total of 3 times. Vital signs such as blood pressure, heart rate, and blood oxygen saturation will be monitored before, during, and after each hyperbaric oxygen therapy. The rest of the treatment is standard medical treatment and monitoring according to the current clinical guideline "2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association" "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023".
OTHERStandard medical treatment
According to the current guideline "2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association" "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023", they receive standard medical treatment and monitoring (including antithrombotic drugs, lipid-lowering drugs, blood pressure management, etc.), not entering the hyperbaric oxygen chamber for treatment.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\~80 years; 2. Clinically diagnosed as acute large vessel occlusive ischemic stroke, suitable for and received endovascular treatment according to current clinical guidelines; 3. The onset of stroke or the last normal time to the time of endovascular treatment ≤ 24 hours; 4. Pre-stroke mRS score of 0 or 1; 5. Baseline NIHSS score before endovascular treatment ≥ 6 points in the anterior circulation or ≥10 points in the posterior circulation; 6. CTA, MRA, or DSA angiography before endovascular treatment confirmed occlusion of large vessels (internal carotid artery, middle cerebral artery M1 segment, basilar artery), consistent with symptoms and signs; 7. The corresponding anterior circulation ASPECTS score or posterior circulation pc-ASPECTS score ≥ 6 points; 8. The pontine midbrain index (PMI) of patients with acute basilar artery occlusion ≤3; 9. Patients or their family members sign the informed consent form.
Exclusion criteria
1. Patients with extensive bleeding or severe increase in infarct area, midline displacement (\>0.5cm), etc. during endovascular treatment, who plan to undergo bone valve decompression or ventricular drainage; 2. Known bleeding risk factors, including coagulation factor deficiency, or receiving anticoagulant therapy, INR\>3.0 or APTT \> 3 times normal or platelet count less than 50×10⁹/L; 3. Severe hepatic or renal dysfunction (severe hepatic dysfunction refers to ALT or AST \> 3 times the upper limit of the normal range, severe renal dysfunction refers to serum creatinine Cr \>1.5 times the upper limit of the normal range); 4. Females of pregnancy, or positive pregnancy test prior to randomization; 5. Severe persistent and medication-uncontrollable hypertension (systolic blood \> 185 mmHg or diastolic blood \> 110 mmHg) 6. Baseline blood glucose of \<50 mg/dL (2.78 mmol/L) or \>400 mg/dL (22.20 mmol/L); 7. The oxygen required to maintain 95% of peripheral arterial oxygen saturation (SaO2) under the current medium-term management guidelines \> 3L/min; 8. End-stage disease other than the nervous system, life expectancy \< 90 days; 9. Participating in other drug or medical device clinical trials; 10. CT or MR suggests intracranial tumors (other than meningiomas) or other high-risk intracranial vascular malformations; 11. Patients with anemia, polycythemia or other conditions requiring urgent oxygen; 12. Unable to cooperate with hyperbaric oxygen therapy, or have other diseases that are not suitable for hyperbaric oxygen therapy (such as active/chronic obstructive pulmonary disease, acute respiratory distress syndrome, tension pneumothorax, tension pneumocephalus, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mRS score distribution at 90 days | 90±14 days after randomization | Modified Rankin Scale (mRS) score distribution at 90 days (±14 days) after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS score 0-1 at 90 days after randomization | 90±14 days after randomization | — |
| mRS score 0-2 at 90 days after randomization | 90±14 days after randomization | — |
| Change in NIHSS score from baseline to 24 hours postoperatively | 24 hours after endovascular treatment | — |
| Change in NIHSS score from baseline to 5 days postoperatively (after the end of hyperbaric oxygen therapy) | 5 days after endovascular treatment | — |
| Recanalization rate of responsible arteries at 24-48h postoperatively | 24-48 hours after endovascular treatment | — |
| Volume of cerebral infarction on the 5th postoperative day or at discharge (after the end of hyperbaric oxygen therapy) | 5 days after endovascular treatment or at discharge | assessed by MRI or CT |
| Total number of days in hospital | From date of randomization until date of hospital discharge, assessed up to 30 days. | Number of days hospitalized (from randomization to hospital discharge) |
| Quality of life EQ-5D-5L score at 90 days after randomization | 90±14 days after randomization | The EuroQoL 5-Dimensions 5-Level (EQ-5D-5L) is a five-dimension, five-level health-related quality of life instrument. Based on the Chinese value set, its utility score ranges from -0.391 to 1.000, with higher scores indicating better outcomes. |
| mRS score 0-1 at 1 year after randomization | 1 year ±30 days after randomization | — |
| mRS score 0-2 at 1 year after randomization | 1 year ±30 days after randomization | — |
Countries
China
Contacts
CONTACTNing Ma, MD
PRINCIPAL_INVESTIGATORNing Ma, MD
Beijing Tiantan Hospital
PRINCIPAL_INVESTIGATORQiuhong Yu, MD
Beijing Tiantan Hospital
PRINCIPAL_INVESTIGATORYuesong Pan, MD
Beijing Tiantan Hospital
Outcome results
None listed