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

NCT ID: NCT07049692

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-03-30

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.

Conditions

Acute Ischemic Stroke

Keywords

HBO; acute ischemic stroke; endovascular treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

hyperbaric oxygen therapy

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type: OTHER

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.

Control group

Group Type: OTHER

Conventional therapy group

Intervention Type: OTHER

Conventional therapy

Interventions

Hyperbaric 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.

Intervention Type: OTHER

Conventional therapy group

Conventional therapy

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing Yang

Hyperbaric Oxygen Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Chaoyang Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

Shuyuan Yuan

Role: CONTACT

Phone: +86 18511703665

Email: shuhua_yuan@126.com

Facility Contacts

Guangxu Liu

Role: primary

Other Identifiers

2025-3-4-2

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-KE-357-2

Identifier Type: -

Identifier Source: org_study_id