A Prospective Cohort Study Exploring the Safety and the Efficiency of Hyperbaric Oxygen in Treating Traumatic Brain Injury During Nonacute Phrase

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Age 18\

⁃ 90 years old

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Zhihua Zhang
2511097@zju.edu.cn
+8613757159433
Backup
Shuyang Li
2323035@zju.edu.cn
+8615167169440
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 300
Treatments
Non-hyperbaric oxygen exposure group
Participants with traumatic brain injuries will always be excluded from hyperbaric oxygen therapy
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: First People's Hospital of Hangzhou, Fu Xing Hospital, Capital Medical University

This content was sourced from clinicaltrials.gov