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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— HOMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05282836
• Other study ID #: HX-A-2021016
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2022
• Source: Beijing Tiantan Hospital
• Contact: Runting Li
• Phone: +8615753166690
• Email: tt18080lrt[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In- hospital Cerebral Vasospasm	The proportion of patients with cerebral vasospasm at day 14	From baseline to 14 days
Primary	In- hospital Delayed Cerebral Ischemia	The proportion of patients with delayed cerebral ischemia at day 14	From baseline to 14 days
Secondary	modified Rankin Scale score	modified Rankin Scale score at 90 days after discharge	90 days after discharge
Secondary	Montreal Cognitive Assessment score	Montreal Cognitive Assessment score at 90 days after discharge	90 days after discharge