- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05282836
Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA) (HOMA)
March 8, 2022 updated by: Beijing Tiantan Hospital
Early Hydrogen-Oxygen Gas Mixture Inhalation Therapy for Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized, Controlled Clinical Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
206
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Runting Li
- Phone Number: +8615753166690
- Email: tt18080lrt@163.com
Study Contact Backup
- Name: Fa Lin
- Phone Number: +8613681107240
- Email: 13681107240@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- Signed informed consent
- Must be admitted within 72 hours after aneurysm rupture
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
H2-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.
|
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.
|
No Intervention: No intervention
Usual care refers to the standard-of-care (including oxygen therapy) recommended by guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In- hospital Cerebral Vasospasm
Time Frame: From baseline to 14 days
|
The proportion of patients with cerebral vasospasm at day 14
|
From baseline to 14 days
|
In- hospital Delayed Cerebral Ischemia
Time Frame: From baseline to 14 days
|
The proportion of patients with delayed cerebral ischemia at day 14
|
From baseline to 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified Rankin Scale score
Time Frame: 90 days after discharge
|
modified Rankin Scale score at 90 days after discharge
|
90 days after discharge
|
Montreal Cognitive Assessment score
Time Frame: 90 days after discharge
|
Montreal Cognitive Assessment score at 90 days after discharge
|
90 days after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 15, 2022
Primary Completion (Anticipated)
March 15, 2023
Study Completion (Anticipated)
March 15, 2024
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HX-A-2021016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aneurysmal Subarachnoid Hemorrhage
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Medical University InnsbruckRecruitingSubarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralAustria
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Fondazione Policlinico Universitario Agostino Gemelli...RecruitingSubarachnoid Hemorrhage, Aneurysmal | Subarachnoid Hemorrhage, SpontaneousItaly
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El Instituto Nacional de Neurologia y Neurocirugia...CompletedBrain Ischemia | Subarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Delayed Cerebral Ischemia | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralMexico
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IRCCS San RaffaeleFondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera... and other collaboratorsRecruitingSubarachnoid Hemorrhage, Aneurysmal | Poor Grade Subarachnoid HemorrhageItaly
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Hackensack Meridian HealthRecruitingStroke | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Cerebral Aneurysm | Cerebral Ischemia | Vasospasm, CerebralUnited States
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University of Texas Southwestern Medical CenterRecruitingSubarachnoid Hemorrhage, AneurysmalUnited States
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Milton S. Hershey Medical CenterRecruiting
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Second Affiliated Hospital, School of Medicine,...RecruitingSubarachnoid Hemorrhage, AneurysmalChina
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First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingAneurysmal Subarachnoid HemorrhageChina
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Ascension South East MichiganRecruitingAneurysmal Subarachnoid HemorrhageUnited States
Clinical Trials on Hydrogen Oxygen Generator with Nebulizer
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Guangzhou Institute of Respiratory DiseaseNot yet recruitingCovid19 | Hydrogen-oxygen Gas | AMS-H-03China
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Guangzhou Institute of Respiratory DiseaseUnknownCovid19 | Hydrogen-oxygen Gas | AMS-H-03China
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Shanghai Zhongshan HospitalRecruitingCOVID-19 | Hydrogen-oxygen Gas | AMS-H-03China
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Ruijin HospitalActive, not recruitingCovid19 | Hydrogen-oxygen Gas | AMS-H-03China
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Guangzhou Institute of Respiratory DiseaseCompletedCovid-19 | Dyspnea | Hydrogen/Oxygen Mixed GasChina
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Guangzhou Institute of Respiratory DiseaseUnknownBronchiectasis | Oxidative Stress | Acute Exacerbation of BronchiectasisChina
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Guangzhou Institute of Respiratory DiseaseUnknown
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Shanghai Asclepius Meditec Inc.The Second Hospital of Hebei Medical University; West China Hospital; The First... and other collaboratorsUnknown
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Shanghai Asclepius Meditec Inc.The Second Hospital of Hebei Medical University; West China Hospital; The First... and other collaboratorsUnknown
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Qingdao UniversityQingdao Hiser Medical GroupRecruitingType 2 DiabetesChina