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

NCT06816199 | Recruiting

• 1 other identifier: 2024-1224
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; hyperbaric oxygen

Outcome Measures

Primary Outcomes (1)

• Extended Glasgow Outcome Scale,GOSE

  Overall functional outcomes for participants with traumatic brain injury

  6-month, 12-month and 24-month after injury

Secondary Outcomes (1)

• Function Independent Measure, FIM

  6-month, 12-month and 24-month after injury

Other Outcomes (1)

• Rivermead Post Concussion Symptoms Questionnaire，RPQ

  6-month, 12-month and 24-month after injury

Study Arms (1)

Non-hyperbaric oxygen exposure group

Participants with traumatic brain injuries will always be excluded from hyperbaric oxygen therapy

Other: Hyperbaric oxygen exposure

Interventions

Hyperbaric oxygen exposure OTHER

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.

Non-hyperbaric oxygen exposure group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Sequelae of previous spinal cord injury or combination of spinal cord injury in this injury;
• Severe coagulation disorders;
• Pregnancy status;
• Any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First People's Hospital of Hangzhou: collaborator
• Fu Xing Hospital, Capital Medical University: collaborator

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (4)

• Maas AIR, Menon DK, Manley GT, Abrams M, Akerlund C, Andelic N, Aries M, Bashford T, Bell MJ, Bodien YG, Brett BL, Buki A, Chesnut RM, Citerio G, Clark D, Clasby B, Cooper DJ, Czeiter E, Czosnyka M, Dams-O'Connor K, De Keyser V, Diaz-Arrastia R, Ercole A, van Essen TA, Falvey E, Ferguson AR, Figaji A, Fitzgerald M, Foreman B, Gantner D, Gao G, Giacino J, Gravesteijn B, Guiza F, Gupta D, Gurnell M, Haagsma JA, Hammond FM, Hawryluk G, Hutchinson P, van der Jagt M, Jain S, Jain S, Jiang JY, Kent H, Kolias A, Kompanje EJO, Lecky F, Lingsma HF, Maegele M, Majdan M, Markowitz A, McCrea M, Meyfroidt G, Mikolic A, Mondello S, Mukherjee P, Nelson D, Nelson LD, Newcombe V, Okonkwo D, Oresic M, Peul W, Pisica D, Polinder S, Ponsford J, Puybasset L, Raj R, Robba C, Roe C, Rosand J, Schueler P, Sharp DJ, Smielewski P, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Temkin N, Tenovuo O, Theadom A, Thomas I, Espin AT, Turgeon AF, Unterberg A, Van Praag D, van Veen E, Verheyden J, Vyvere TV, Wang KKW, Wiegers EJA, Williams WH, Wilson L, Wisniewski SR, Younsi A, Yue JK, Yuh EL, Zeiler FA, Zeldovich M, Zemek R; InTBIR Participants and Investigators. Traumatic brain injury: progress and challenges in prevention, clinical care, and research. Lancet Neurol. 2022 Nov;21(11):1004-1060. doi: 10.1016/S1474-4422(22)00309-X. Epub 2022 Sep 29.

  PMID: 36183712 BACKGROUND

• Kowalski RG, Hammond FM, Weintraub AH, Nakase-Richardson R, Zafonte RD, Whyte J, Giacino JT. Recovery of Consciousness and Functional Outcome in Moderate and Severe Traumatic Brain Injury. JAMA Neurol. 2021 May 1;78(5):548-557. doi: 10.1001/jamaneurol.2021.0084.

  PMID: 33646273 BACKGROUND

• McCrea MA, Giacino JT, Barber J, Temkin NR, Nelson LD, Levin HS, Dikmen S, Stein M, Bodien YG, Boase K, Taylor SR, Vassar M, Mukherjee P, Robertson C, Diaz-Arrastia R, Okonkwo DO, Markowitz AJ, Manley GT; TRACK-TBI Investigators; Adeoye O, Badjatia N, Bullock MR, Chesnut R, Corrigan JD, Crawford K, Duhaime AC, Ellenbogen R, Feeser VR, Ferguson AR, Foreman B, Gardner R, Gaudette E, Goldman D, Gonzalez L, Gopinath S, Gullapalli R, Hemphill JC, Hotz G, Jain S, Keene CD, Korley FK, Kramer J, Kreitzer N, Lindsell C, Machamer J, Madden C, Martin A, McAllister T, Merchant R, Ngwenya LB, Noel F, Nolan A, Palacios E, Perl D, Puccio A, Rabinowitz M, Rosand J, Sander A, Satris G, Schnyer D, Seabury S, Sherer M, Toga A, Valadka A, Wang K, Yue JK, Yuh E, Zafonte R. Functional Outcomes Over the First Year After Moderate to Severe Traumatic Brain Injury in the Prospective, Longitudinal TRACK-TBI Study. JAMA Neurol. 2021 Aug 1;78(8):982-992. doi: 10.1001/jamaneurol.2021.2043.

  PMID: 34228047 BACKGROUND

• Schimmel S, El Sayed B, Lockard G, Gordon J, Young I, D'Egidio F, Lee JY, Rodriguez T, Borlongan CV. Identifying the Target Traumatic Brain Injury Population for Hyperbaric Oxygen Therapy. Int J Mol Sci. 2023 Sep 27;24(19):14612. doi: 10.3390/ijms241914612.

  PMID: 37834059 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Zhihua Zhang

  Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Sujuan Li

  Fu Xing Hospital, Capital Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhihua Zhang

CONTACT

+8613757159433; 2511097@zju.edu.cn

Shuyang Li

CONTACT

+8615167169440; 2323035@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

CN (1)