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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-3-4-2 | Registry Identifier | NOTICE-1 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyperbaric oxygen therapy | Experimental |
| |
| Control group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 10 (±1)post-randomization |
| National Institutes of Health Stroke Scale (NIHSS)score [(0, Normal)-(42, worst)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuyuan Yuan | Contact | +86 18511703665 | shuhua_yuan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | China |
31/12/2028-31/12/2043
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.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| Conventional therapy group | Other | Conventional therapy |
|
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. |
| 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 | 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. | Day 90 (±7) post-randomization |
| Bartherl index (BI)[(0, worst)-(100, normal)] | Functional independence was assessed using the BI | 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. | 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. | Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |