The influence of 100% oxygen inhaled under hyperbaric conditions on traumatic injury of the spinal cord.

Hyperbaric Oxygenation (HBO) in traumatic spinal cord injury.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002130-72-AT

Enrollment

Registered

2016-06-28

Start date

2016-08-08

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We want to investigate the effect of hyperbaric oxygen therapy on the neurological and clinical outcome following traumatic injury of the spinal cord.

Interventions

Trade Name: Oxygen Product Name: Oxygen, hyperbaric Pharmaceutical Form: Inhalation vapour INN or Proposed INN: OXYGEN CAS Number: 7782-44-7 Other descriptive name: Pure Oxygen Concentration unit: % (

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Austria

Contacts

Public ContactClinical Trials Information

Medical University of Graz

andreja.glavina@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026