Aneurysmal Subarachnoid Hemorrhage
Conditions
Brief summary
This was a randomized, single-center trial. On the basis of standard-of-care, patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. Patients in the control group received standard-of-care (consisting of oxygen therapy) alone. This study intends to apply Hydrogen/Oxygen Generator in clinical patients with aneurysmal subarachnoid hemorrhage (aSAH), exploring the role of hydrogen-oxygen mixed gas inhalation therapy in early brain injury, and the prevention of cerebral vasospasm and delayed cerebral ischemia, finally providing a scientific basis for hydrogen treatment of aSAH.
Interventions
Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Signed informed consent 3. Must be admitted within 72 hours after aneurysm rupture
Exclusion criteria
1. physical disability caused by any reason before the onset of the disease 2. dementia or mental illness before the onset of the disease 3. more than 72 hours after aneurysm rupture admitted to hospital for treatment 4. do not cooperate with the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In- hospital Cerebral Vasospasm | From baseline to 14 days | The proportion of patients with cerebral vasospasm at day 14 |
| In- hospital Delayed Cerebral Ischemia | From baseline to 14 days | The proportion of patients with delayed cerebral ischemia at day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale score | 90 days after discharge | modified Rankin Scale score at 90 days after discharge |
| Montreal Cognitive Assessment score | 90 days after discharge | Montreal Cognitive Assessment score at 90 days after discharge |
Contacts
Primary ContactRunting Li
Backup ContactFa Lin
Outcome results
None listed