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

Last updated: February 4, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Traumatic Brain Injury

Memory Loss

Treatment

Hyperbaric oxygen exposure

Clinical Study ID

NCT06816199
2024-1224
  • Ages 18-90
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 18~90 years old

  2. Patients with traumatic brain injury admitted to the rehabilitation department meetone of the following indicators:

  1. Clear history of exogenous trauma-causing disease (such as car accidents, heavyobjects, falls, violent assaults, explosive injuries, etc.) 2) GCS score of 3 to 15points (excluding all kinds of poisoning, sedation, shock factors) 3. Clear presenceof at least one of the following imaging signs on cranial CT or MRI: Traumaticintracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion,ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. goodcompliance, signed informed consent, and those who were judged by the investigatorto be eligible for enrollment.

Exclusion

Exclusion Criteria:

  1. Sequelae of previous spinal cord injury or combination of spinal cord injury in thisinjury;

  2. Severe coagulation disorders;

  3. Pregnancy status;

  4. Any other factors that the investigator considers to be a potential risk to thesubject or that interfere with the subject.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Hyperbaric oxygen exposure
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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