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The Study on the Efficacy of Hyperbaric Oxygen Therapy in Treating Acute Ischemic Cerebral Infarction in High Altitude

The randomized controlled trial study on the relationship between hyperbaric oxygen therapy and neurological function prognosis in patients with acute ischemic stroke in high altitude areas after intravenous thrombolysis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090500
Enrollment
Unknown
Registered
2024-10-06
Start date
2024-10-06
Completion date
Unknown
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Intervention group.:After receiving the standard dose of rt-PA intravenous thrombolysis, the intervention group was given HBO therapy (treatment in a hyperbaric chamber at 2.0 ATA and 100% O2 for 1 ho
Control group.:After receiving the standard dose of rt-PA intravenous thrombolysis, the intervention group was given NBO therapy (treatment in a normobaric chamber at 1.0 ATA and 100% O2 for 1 hour, o

Sponsors

Xining Third People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Native plateau residents aged 18-80 years; 2 within 6 hours of onset; 3 Acute ischemic stroke confirmed by CT or MR; 4. The signs of brain damage persisted for more than one hour and were more serious; 5 Brain NCCT has ruled out intracranial hemorrhage, and there is no early massive cerebral infarction imaging changes.

Exclusion criteria

Exclusion criteria: 1. Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; (2) a history of intracranial trauma in the past 3 months; 3. Gastrointestinal or urinary tract bleeding within the last 3 weeks; 4. Major surgical operation within the last 2 weeks; 5. Puncture of large arteries in areas not easy to compress hemostasis within the past week; 6. History of cerebral infarction or myocardial infarction within the past 3 months, excluding old small lacunar brain Infarction without signs of neurological deficit; 7. Patients with severe heart, liver, kidney dysfunction or severe diabetes mellitus; 8. Evidence of active bleeding or trauma (e.g., fracture) on physical examination; 9. Oral anticoagulants and INR > 1.5; Heparin therapy (APTT ultrasonographic) within 48 hours Out of normal range). 10. Platelet count less than 100×109/L; 11. Blood glucose 180mmHg (1 mmHg=0.1333 kPa), diastolic pressure > 100 mmHg; 13. Pregnancy; 14. Not cooperating; 15. Mechanical thrombectomy was performed to bridge the patient after intravenous thrombolysis; 16. Relative/absolute contraindications of hyperbaric oxygen therapy: pneumothorax, multiple rib fractures, and open chest Trauma, cavitary pulmonary tuberculosis, retinal detachment, etc.

Design outcomes

Primary

MeasureTime frame
The mRS score at 90 days post-onset.;

Secondary

MeasureTime frame
The NIHSS score at 90 days post-onset.;Symptomatic intracranial hemorrhage.;The degree of improvement of mRS Score at 90 (±7) days;

Countries

China

Contacts

Public ContactXiqiang Zhang

Xining Third People’s Hospital

1370350750@qq.com+86 189 9716 8296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026