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Efficacy and safety of sequential hydrogen inhalation and hyperbaric oxygen therapy in patients with moderate to severe traumatic brain injury: a prospective, randomized, double-blind, controlled trial

Efficacy and safety of sequential hydrogen inhalation and hyperbaric oxygen therapy in patients with moderate to severe traumatic brain injury: a prospective, randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047745
Enrollment
Unknown
Registered
2021-06-26
Start date
2021-11-05
Completion date
Unknown
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Interventions

Treatment group:Sequential hydrogen inhalation and hyperbaric oxygen therapy on the basis of conventional treatment and nursing
Control group:Hyperbaric oxygen therapy on the basis of conventional treatment and nursing

Sponsors

The Sixth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Subjects aged 18 to 65 years, at the time of signing the informed consent; 2.Subjects who have suffered from moderate to severe traumatic brain injury combined with obvious contusion and laceration in CT imaging; 3.Within 72 hours after injury.

Exclusion criteria

Exclusion criteria: 1.Operation was performed 48 hours after injury; 2.Respiratory failure caused by severe lung disease; 3.Have a history of serious dysfunction of other organs outside the brain, such as heart, liver, kidney, coagulation dysfunction, etc; 4.Severe brain stem injury, simple epidural hematoma, intracranial infection; 5.History of neurological and psychiatric diseases affecting neurological function scores; 6.Participation in another experimental trial with active interventions; 7.Pregnant or lactating patients; 8.The researchers believe that others are not suitable to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Glasgow coma scale;extended Glasgow Outcome Scale score;Barthel index;

Secondary

MeasureTime frame
Brain functional magnetic resonance;Electroencephalogram;Cerebrospinal fluid test;Blood test;

Countries

China

Contacts

Public ContactGuo Dazhi

The Sixth Medical Center of PLA General Hospital

guodazhigod1983@163.com+86 18600317342

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026