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Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy

Evaluation of the Efficacy and Safety of Hyperbaric Oxygen in Patients After Endovascular Treatment for Acute Ischemic Stroke: A Multicenter, Open-label, Randomized Controlled Clinical Trial

NCT07049692•Beijing Chao Yang Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 75 years

Sex

ALL

Healthy Volunteers

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);
+9 more criteria

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

March 30, 2028

Completion Date

March 30, 2028

Last Updated

December 31, 2025

Enrollment

424

ESTIMATED participants

Conditions

Acute Ischemic Stroke

Interventions

Hyperbaric Oxygen Therapy

OTHER

Conventional therapy group

OTHER

Contacts

Shuyuan Yuan

CONTACT

+86 18511703665 shuhua_yuan@126.com

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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Acute Ischemic StrokeLarge Vessel Occlusion+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy

Inclusion Criteria

Exclusion Criteria

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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