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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05282836

Collaborator

(none)

206

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage	Device: Hydrogen Oxygen Generator with Nebulizer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Early Hydrogen-Oxygen Gas Mixture Inhalation Therapy for Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized, Controlled Clinical Trial

Anticipated Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

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.	Device: Hydrogen Oxygen Generator with Nebulizer 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.

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.

Device: Hydrogen Oxygen Generator with Nebulizer

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT05282836

Other Study ID Numbers:

HX-A-2021016

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Subarachnoid Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Mar 16, 2022