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
- EUCTR2018-004679-11-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
- 100
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: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 Main Objective: We aim at testing the hypothesis that hyperbaric oxygen therapy (HBO- therapy) leads to an improvement of neurological deficits caused by spinal cord lesions. Furthermore, we want to correlate the clinical observations with blood parameters from routinely taken blood tests.;Secondary Objective: Not applicable.;Primary end point(s): Effect of hyperbaric oxygen therapy on recovery and outcome following spinal cord injury.<br><br>Comparison of clinical, radiological and neurological outcome with molecular blood markers.;Timepoint(s) of evaluation of this end point: After all 21 HBO-sessions have been completed (and blood results from last blood test have been analysed.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.