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Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA) (HOMA)

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrogen Oxygen Generator with Nebulizer
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    No intervention

    Arm Description

    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.

    Usual care refers to the standard-of-care (including oxygen therapy) recommended by guidelines.

    Outcomes

    Primary Outcome Measures

    In- hospital Cerebral Vasospasm
    The proportion of patients with cerebral vasospasm at day 14
    In- hospital Delayed Cerebral Ischemia
    The proportion of patients with delayed cerebral ischemia at day 14

    Secondary Outcome Measures

    modified Rankin Scale score
    modified Rankin Scale score at 90 days after discharge
    Montreal Cognitive Assessment score
    Montreal Cognitive Assessment score at 90 days after discharge

    Full Information

    First Posted
    March 8, 2022
    Last Updated
    March 8, 2022
    Sponsor
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05282836
    Brief Title
    Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA)
    Acronym
    HOMA
    Official Title
    Early Hydrogen-Oxygen Gas Mixture Inhalation Therapy for Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized, Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2022 (Anticipated)
    Primary Completion Date
    March 15, 2023 (Anticipated)
    Study Completion Date
    March 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Tiantan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aneurysmal Subarachnoid Hemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    206 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Arm Description
    Usual care refers to the standard-of-care (including oxygen therapy) recommended by guidelines.
    Intervention Type
    Device
    Intervention Name(s)
    Hydrogen Oxygen Generator with Nebulizer
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    In- hospital Cerebral Vasospasm
    Description
    The proportion of patients with cerebral vasospasm at day 14
    Time Frame
    From baseline to 14 days
    Title
    In- hospital Delayed Cerebral Ischemia
    Description
    The proportion of patients with delayed cerebral ischemia at day 14
    Time Frame
    From baseline to 14 days
    Secondary Outcome Measure Information:
    Title
    modified Rankin Scale score
    Description
    modified Rankin Scale score at 90 days after discharge
    Time Frame
    90 days after discharge
    Title
    Montreal Cognitive Assessment score
    Description
    Montreal Cognitive Assessment score at 90 days after discharge
    Time Frame
    90 days after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Runting Li
    Phone
    +8615753166690
    Email
    tt18080lrt@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fa Lin
    Phone
    +8613681107240
    Email
    13681107240@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA)

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