Clinical trial NCT06816199: The Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury
Official title: A Prospective Cohort Study Exploring the Safety and the Efficiency of Hyperbaric Oxygen in Treating Traumatic Brain Injury During Nonacute Phrase
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
hyperbaric oxygen
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Hangzhou
name: Fu Xing Hospital, Capital Medical University
First posted: 2025-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this observational cohort study, all patients with craniocerebral injuries who satisfy the enrollment requirements and do not meet the exclusion criteria will be included.

Brief 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.

Detailed description: 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). This is a multicenter prospective cohort study.

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 during non-acute phrase after injury, they will answer online or telephone survey questions about their functional independence (including cognitive functioning, physical disability, mental status, employment and social activities) for 2 years.

Eligibility criteria: Inclusion Criteria:

1. Age 18\~90 years old
2. Patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators:

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 outcomes:
measure: Extended Glasgow Outcome Scale,GOSE
timeFrame: 6-month, 12-month and 24-month after injury
Secondary outcomes:
measure: Function Independent Measure, FIM
timeFrame: 6-month, 12-month and 24-month after injury
Other outcomes:
measure: Rivermead Post Concussion Symptoms Questionnaire，RPQ
timeFrame: 6-month, 12-month and 24-month after injury
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine
name: Zhihua Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Xing Hospital, Capital Medical University
name: Sujuan Li
role: STUDY_DIRECTOR
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