Acute Ischemic StrokeNOTICE-1NCT07049692
Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy
A study testing Hyperbaric Oxygen Therapy and Conventional therapy group in people with Acute Ischemic Stroke, run by Beijing Chao Yang Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Hyperbaric Oxygen Therapy and Conventional therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jul 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Emergency Intensive Care Unit
Beijing, Beijing Municipality
shuhua Yuan, PhD, +86 18511703655, shuhua_yuan@126.com
- Not yet recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Guangxu Liu, +86 010-85231129, bjcyh_yjxbf@163.com
About this study
Official title: 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
- The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment
- The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment?
- 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
- Being tested
- Hyperbaric Oxygen Therapy, Conventional therapy group
- Keywords
- HBO, acute ischemic stroke, endovascular treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
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.
Conventional therapy groupOther
Conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | Not described Receives: Other: Hyperbaric Oxygen Therapy |
| Control group | Other | Not described Receives: Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90 (±7) post-randomization
Secondary outcomes (7)
Core infarction volume on Diffusion-Weighted Imaging
The effectiveness of HBO for patients with acute ischemic stroke was evaluated based on the core cerebral infarction volume.
Measured: Day 10 (±1）post-randomization
National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)]
The effectiveness of HBO therapy in patients with acute ischemic stroke undergoing endovascular treatment was evaluated based on the improvement rate of NIHSS score day 10 post-randomization.
Measured: Day 10(±1) NIHSS score post-randomization
mRS score [ (0, Normal)-(6, worst)]
To assess the effectiveness of HBO treament for ischemic stroke using mRS score on day 10, 30, 90 and 360 post-randomization
Measured: 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)]
mRS (0-1): the proportion of functional independence; mRS (0-2): the proportion of good prognosis; mRS (4-6) : the proportion of severe disability.
Measured: Day 90 (±7) post-randomization
Bartherl index (BI)[(0, worst)-(100, normal)]
Functional independence was assessed using the BI
Measured: Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization
EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)]
Health-related quality of life was measured using EQ-5D.
Measured: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization
Stroke recurrence rate
New symptoms persisting for > 24 hours and new lension on the DWI.
Measured: Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start22 Jul 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Yang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049692
- Sponsor's protocol ID
- 2025-KE-357-2
- Other IDs
- 2025-3-4-2
- Acronym
- NOTICE-1
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Primary/secondary efficacy endpoint data 2. Safety data 3. Baseline characteristic dataset 4. Plan Deviation Record
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07049692
- Acronym / sponsor ID
- NOTICE-1 / 2025-KE-357-2
- Conditions
- Acute Ischemic Stroke
- Keywords
- HBO, acute ischemic stroke, endovascular treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment
- The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | Other: Hyperbaric Oxygen Therapy |
| Control group | Other | Other: Conventional therapy group |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy1.6 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. | Other | hyperbaric oxygen therapy |
| Conventional therapy groupConventional therapy | Other | Control group |
Primary outcome
The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days
Time frame: Day 90 (±7) post-randomization
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.
7 secondary outcomes
Core infarction volume on Diffusion-Weighted Imaging
Time frame: Day 10 (±1）post-randomization
National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)]
Time frame: Day 10(±1) NIHSS score post-randomization
mRS score [ (0, Normal)-(6, worst)]
Time frame: 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)]
Time frame: Day 90 (±7) post-randomization
Bartherl index (BI)[(0, worst)-(100, normal)]
Time frame: Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization
EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)]
Time frame: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization
Stroke recurrence rate
Time frame: Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. 1. Primary/secondary efficacy endpoint data 2. Safety data 3. Baseline characteristic dataset 4. Plan Deviation Record
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy and Conventional therapy group in people with Acute Ischemic Stroke, run by Beijing Chao Yang Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuyuan Yuan (+86 18511703665, shuhua_yuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days (time frame: Day 90 (±7) post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.