The influence of 100% oxygen inhaled under hyperbaric conditions on traumatic injury of the spinal cord.
Phase 1
- Conditions
- We want to investigate the effect of hyperbaric oxygen therapy on the neurological and clinical outcome following traumatic injury of the spinal cord.Therapeutic area: Body processes [G] - Biological Phenomena [G16]
- Registration Number
- EUCTR2016-002130-72-AT
- Lead Sponsor
- Division of Thoracic and Hyperbaric Surgery, Medical University Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age 16 - 70 years
Traumatic spinal cord injury
Vertebral column stable
No significant compression of spinal cord
Circumstances allowing HBO to be started within 24 h following trauma
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
Morphologically confirmed complete discontinuation of spinal cord
Cardiorespiratory instability
Cystic/bullous lung disease
Untreated pneumothorax
Pregnancy
Sepsis, SIRS
Treatment with doxorubicin in patient's history
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method