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

NCT07049692 | Not Yet Recruiting

• 2 other identifiers: 2025-KE-357-22025-3-4-2
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.The main questions it aims to answer is:
3. 3.Participants will:

Conditions

Acute Ischemic Stroke

Keywords

HBO; acute ischemic stroke; endovascular treatment

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days

  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.

  Day 90 (±7) post-randomization

Secondary Outcomes (7)

• Core infarction volume on Diffusion-Weighted Imaging

  Day 10 (±1）post-randomization

• National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)]

  Day 10(±1) NIHSS score 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.

• Distribution of mRS score [(0, normal)-6(worst)]

  Day 90 (±7) post-randomization

• Bartherl index (BI)[(0, worst)-(100, normal)]

  Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization

Study Arms (2)

hyperbaric oxygen therapy

EXPERIMENTAL

Other: Hyperbaric Oxygen Therapy

Control group

OTHER

Other: Conventional therapy group

Interventions

Hyperbaric Oxygen Therapy 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.

hyperbaric oxygen therapy

Conventional therapy group OTHER

Conventional therapy

Control group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Shuyuan Yuan

CONTACT

+86 18511703665; shuhua_yuan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hyperbaric Oxygen Department

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 31/12/2028-31/12/2043
• Access Criteria: Qualified researchers can access de-identified IPD, protocols, and analysis plans through \[Repository Name\] after submitting a research proposal and signing a Data Use Agreement. Data is available in CDISC formats for non-commercial research only, with results required within 24 months. Re-identification and commercial use are prohibited.

Locations

CN (1)