Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA)
HOMA
1 other identifier
interventional
206
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedMarch 16, 2022
March 1, 2022
1 year
March 8, 2022
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
In- hospital Cerebral Vasospasm
The proportion of patients with cerebral vasospasm at day 14
From baseline to 14 days
In- hospital Delayed Cerebral Ischemia
The proportion of patients with delayed cerebral ischemia at day 14
From baseline to 14 days
Secondary Outcomes (2)
modified Rankin Scale score
90 days after discharge
Montreal Cognitive Assessment score
90 days after discharge
Study Arms (2)
Intervention
EXPERIMENTALH2-O2 (66% hydrogen; 33% oxygen) inhalation. 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.
No intervention
NO INTERVENTIONUsual care refers to the standard-of-care (including oxygen therapy) recommended by guidelines.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Signed informed consent
- Must be admitted within 72 hours after aneurysm rupture
You may not qualify if:
- physical disability caused by any reason before the onset of the disease
- dementia or mental illness before the onset of the disease
- more than 72 hours after aneurysm rupture admitted to hospital for treatment
- do not cooperate with the treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lin F, Li R, Chen Y, Yang J, Wang K, Jia Y, Han H, Hao Q, Shi G, Wang S, Zhao Y, Chen X. Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients with Aneurysmal Subarachnoid Hemorrhage (HOMA): study protocol for a randomized controlled trial. Trials. 2024 Jun 11;25(1):377. doi: 10.1186/s13063-024-08231-5.
PMID: 38863026DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2022
First Posted
March 16, 2022
Study Start
March 15, 2022
Primary Completion
March 15, 2023
Study Completion
March 15, 2024
Last Updated
March 16, 2022
Record last verified: 2022-03