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Clinical Trials in China / NCT06816199
Recruiting Observational

the Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury

NCT06816199 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2025-02-10
Last updated
2026-11-04

Condition(s) studied

Traumatic Brain Injury

Investigational drug(s) / intervention(s)

Hyperbaric oxygen exposure

Hyperbaric oxygen exposure: Between 1 week and 3 months after the traumatic brain injury, participants will receive hyperbaric oxygen therapy on a 2.0 ATA protocol for 60 minutes once a day, five times a week.

Study summary

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI).

The main question it aims to answer are:

Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI, they will answer online or telephone survey questions about their functional independence for 2 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18\~90 years old 2. Patients with traumatic brain injury admitted to the rehabilitation department who met the following inclusion criteria: 1\) Clear history of exogenous trauma-causing disease (such as car accidents, heavy objects, falls, violent assaults, explosive injuries, etc.) 2) GCS score of 3 to 15 points (excluding all kinds of poisoning, sedation, shock factors) 3. Clear presence of at least one of the following imaging signs on cranial CT or MRI: Traumatic intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. good compliance, signed informed consent, and those who were judged by the investigator to be eligible for enrollment. Exclusion Criteria: 1. Sequelae of previous spinal cord injury or combination of spinal cord injury in this injury; 2. Severe coagulation disorders; 3. Pregnancy status; 4. Any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject.

Primary outcome measure(s)

  • Extended Glasgow Outcome Scale,GOSE — 6-month, 12-month and 24-month after injury
    Overall functional outcomes for participants with traumatic brain injury

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06816199 on ClinicalTrials.gov ↗ ← All trials in China