Hydrogen Gas Therapy for Brain Hemorrhage Patients Study Protocol

Authors
Journal
Trials
Year
DOI
10.1186/s13063-024-08231-5
Study Type
clinical
Peer Reviewed
Yes
Country
China
Health Condition
Aneurysmal Subarachnoid Hemorrhage
Body System
Neurological

TL;DR

Doctors are testing whether breathing in a special mixture of hydrogen and oxygen gas can help people who have had a serious type of brain bleed recover better by preventing dangerous complications that happen days after the injury.

Key Finding

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Summary

This is a study protocol (a plan for a future study) describing a clinical trial that will test whether breathing a mixture of hydrogen and oxygen gas can help patients who have suffered a ruptured brain aneurysm (a burst blood vessel in the brain). The study will compare patients who receive the hydrogen-oxygen mixture to those who receive oxygen alone, measuring whether the treatment prevents complications like reduced blood flow to the brain that commonly occur after this type of injury.

Practical Takeaway

This is a study protocol describing a planned trial, not a completed study with results, so there are no findings yet to apply. The HOMA trial aims to be the first large-scale test of hydrogen therapy in aneurysm patients, but consumers should wait for actual results before drawing any conclusions about whether this treatment works.

Abstract

Background: Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening neurosurgical emergency with a high mortality rate. Delayed cerebral ischemia (DCI) and cerebral vasospasm (CVS) are delayed products of early brain injury (EBI), which may constitute the principal determinant of an unfavorable patient prognosis. Consequently, the mitigation of DCI and CVS assumes paramount significance in the pursuit of enhanced patient outcomes. However, except for oral nimodipine, there is no effective therapy available in the current guideline. Hence, the exigency arises to proffer novel treatment paradigms. The diversity of hydrogen therapeutic targets has been largely reported in basic research, unveiling its latent capacity to ameliorate EBI in aSAH patients. Methods: Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients with Aneurysmal Subarachnoid Hemorrhage (HOMA), a single-center, prospective, open-labeled, randomized controlled clinical trial, endeavors to evaluate the efficacy and safety of hydrogen-oxygen gas mixture inhalation therapy in aSAH patients. A cohort of 206 patients will be randomized to either hydrogen-oxygen gas mixture inhalation group (8 h per day, 3 L/min, hydrogen concentration of 67%, oxygen concentration of 33%) or oxygen inhalation group (8 h per day, 3 L/min, oxygen concentration of 33%) within 72 h after aSAH and treated for 7 days in the ICU ward. The primary outcomes are the incidence of DCI and CVS during hospitalization. Discussion: The HOMA aims to evaluate the effectiveness of hydrogen-oxygen gas mixture inhalation therapy in preventing DCI or CVS and improving outcomes in aSAH patients. Notably, this is the first large-scale trial of hydrogen therapy in aSAH patients. Given that the Chinese population represents a significant portion of the global population and the increasing incidence of stroke due to aging, optimizing patient care is vital. Given the current challenges in aSAH patient outcomes, initiating more prospective clinical trials is essential. Recent research has shown hydrogen's therapeutic potential, aligning with EBI in aSAH, driving our exploration of hydrogen therapy's mechanisms in post-aneurysm rupture damage. Ethics and dissemination: The protocol for the HOMA study was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY 2022-020-02). All results of the present study will be published in peer-reviewed journals and presented at relevant conferences.