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Recruiting
NCT07626450
HBO After Thrombectomy for AIS With LVO
Conditions: Acute Ischemic Stroke From Large Vessel Occlusion
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 420
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tiantan Hospital Beijing Beijing Municipality
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.
Eligibility Criteria
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 \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.).
Source: ClinicalTrials.gov (NCT07626450). StuddyBuddy aggregates publicly available trial information.
