2024 · Lin — Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients with Aneurysmal Subarachnoid Hemorrhage (HOMA): study protocol for a randomized controlled trial.
Super-Abstract
This is the published protocol for the first large-scale randomised controlled trial of hydrogen therapy in aneurysmal subarachnoid haemorrhage (aSAH): 206 patients will inhale a 67% hydrogen / 33% oxygen gas mixture for 8 hours daily in the ICU, targeting delayed cerebral ischaemia and cerebral vasospasm. This is a protocol paper — results are not yet available. (Trials, 2024.)
Commentary
Aneurysmal subarachnoid haemorrhage carries brutal outcomes: high mortality, and among survivors, devastating neurological sequelae from delayed cerebral ischaemia (DCI) and vasospasm. Beyond oral nimodipine, the current guideline offers almost nothing for DCI prevention. This trial — registered NCT05282836 — is significant because it is the first adequately powered (n=206), prospective, randomised attempt to test hydrogen in this indication. The choice of 67% H₂ / 33% O₂ at 3 L/min for 8 hours daily is specific and safety-tested in prior smaller studies. The primary endpoints (DCI and vasospasm incidence during hospitalisation) are clinically hard and relevant. When results emerge, this trial has the potential to either establish or refute hydrogen's role in post-haemorrhage brain protection.
Key quotes
- „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.“ — the trial objective: hard neurological endpoints in a high-mortality population
- „this is the first large-scale trial of hydrogen therapy in aSAH patients.“ — the significance statement: no prior powered trial in this indication exists
- „except for oral nimodipine, there is no effective therapy available in the current guideline.“ — the unmet medical need that motivates the trial
Our assessment
A well-designed protocol with appropriate sample size (n=206), a hard primary endpoint, and a registered trial number. Important caveat: this is a protocol paper — no efficacy or safety results are available. The trial design is sound: open-label RCT, single centre, 7-day treatment window starting within 72h of aSAH, comparison against oxygen-only inhalation. Limitations of the design include open-label (not blinded), single-centre, and the Chinese population context. Results, when published, will be a landmark for H₂ research in neurocritical care.
Study design
- Type: published RCT protocol (results not yet available) · n planned: 206 patients with aneurysmal SAH · H₂ delivery: 67% H₂ / 33% O₂ gas mixture inhalation, 3 L/min, 8 h/day for 7 days
- Comparator: oxygen inhalation only (33% O₂, 3 L/min, 8 h/day) · Timing: initiated within 72 h of aSAH, in ICU setting
- Primary endpoints: incidence of delayed cerebral ischaemia (DCI) and cerebral vasospasm (CVS) during hospitalisation · Registration: ClinicalTrials.gov NCT05282836
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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05282836. Registered on March 16, 2022.
Source & links
Screenshot of the PubMed page
This page mirrors the published abstract (© the authors / publisher) for reference and citation. The canonical source is the PubMed record linked above. This is not medical advice.