AzTrials
AzTrials

Traumatic Injury of the Spinal CordPhase 2NCT03101982

Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study

A Phase 2 study testing HBO in people with Traumatic Injury of the Spinal Cord, run by Medical University of Graz at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Hypothesis of the Study: Based on the presented results, the investigator hypothesises that HBO preserves neurons that are not irreversibly damaged (i.e. severed) during initial trauma, thus enabling regain of their function. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Traumatic Injury of the Spinal Cord
What is being tested?
HBO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteAustria
Study dates
18 Apr 2017to 20 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Test cohort and control cohort:
  • age: 16 to 70 years
  • Traumatic spinal cord injury
  • Initial incomplete or complete (ASIA) sensor/motoric dysfunction
  • Mentally competent patient (no mental disability in history in case of intubated patient)
  • No relevant neuromuscular diseases / neurological deficits before trauma
Show all 12Show fewer
  • Vertebral column stable, no relevant mechanical compression of spinal cord with our without surgical intervention within 24 hours after the injury;
  • Spinal MRI and CT-scan within first 24 hours
  • Test cohort only:
  • Cardiorespiratory situation allowing safe application of HBO
  • Ability to equalize pressure differences in middle ear confirmed by an ENT (ear, nose, throat) physician or pretherapeutic myringotomy
  • Circumstances allowing HBO-treatment to be started < 24 hours after the injury

Who cannot join

  • Test cohort and control cohort:
  • Morphologically confirmed complete discontinuation of the spinal cord
  • Cardio-respiratory instability
  • Persistent seizure activity in spite of medication
  • Craniocerebral injury exceeding mere commotion
  • Pregnancy
Show all 11Show fewer
  • Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
  • Simultaneous participation in another interventional study if relevant
  • Test cohort only:
  • Cystic or bullous lung disease, untreated pneumothorax
  • Treatment with doxorubicin in patient´s history

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University Graz

    Graz

Other trials in Austria

About this study

Hypothesis of the Study:

Based on the presented results, the investigator hypothesises that HBO preserves neurons that are not irreversibly damaged (i.e. severed) during initial trauma, thus enabling regain of their function. The investigator predicts that HBO treatment protects and enhances motor function in initially paralysed regions, including improvement in function of the extremities as well as recovery of urinary bladder control and bowel function.

Read more

Outline of the Proposed Study:

Within a prospective "proof of principle" trial, a total of 100 patients will be included. Fifty patients will be recruited at the Division of Thoracic and Hyperbaric Surgery, Medical University of Graz. In parallel, 50 control patients will be included at the Department of Orthopaedics and Trauma, Paracelsus University Salzburg, Salzburger Landeskliniken (SALK), Austria. Thereby, all patients that are admitted at the Medical University of Graz can be treated and the enrolment of 50 patients into the treatment group can be implemented within the outlined time frame. The active recruitment period is planned for three years. Both HBO treated and control patients will undergo the same surgical and nonsurgical procedures. HBO treatment will be started within 24 hours after the injury. A total of 21 consecutive daily sessions will be applied, followed by routine rehabilitation programmes. By matching control and HBO-treated patients, an evaluation of the treatment effect of HBO is possible. The outcome will be evaluated by implementing the American Spinal Injury Association (ASIA)-scores and magnet resonance (MR) imaging. Additionally, inflammatory and regenerative blood markers will be analysed (neuroendocrine markers/neuro-transmitters: S100beta, Brain Derived Neurotrophic Growth Factor [BDNF], Glial Fibrillary Acidic Protein [GFAP], Reactive Oxygen Species (ROS), norepinephrine; array of pro- and anti-inflammatory cytokines and chemokines).

Being tested
HBO

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HBODrug

    Also called Hyperbaric oxygenation

    Hyperbaric oxygenation (HBO) is defined as breathing of 100% oxygen under elevated ambient pressure in a hyperbaric chamber. HBO is considered a pharmacological therapy.

Study groups in NCT03101982
Study groupRoleWhat they receive
testActive comparatorHBO, ASIA score, blood taking
Receives: Drug: HBO
controlNo interventionASIA score, blood taking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of neurological deficits caused by spinal cord lesions

    assessed by American Spinal Injury Association (ASIA) scores

    Measured: Change from baseline-admission scores ( ASIA ) at 12 months

  2. Correlation of clinical observations with blood parameters

    assessed by routinely taken blood tests

    Measured: Blood samples will be taken at the time of admission, immediately before the first HBO, immediately after the first HBO, on days 1, 3, 7, 14 , 21 before the respective HBO, and at the 35 days and two months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2017
  2. Study start18 Apr 2017
  3. Primary completion20 Dec 2024
  4. Study completion20 Dec 2024

Why it stopped: less of patients enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03101982
Sponsor's protocol ID
HBOwings
Status last verified
Mar 2023
First submitted
22 Mar 2017
Last updated
9 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HBO in people with Traumatic Injury of the Spinal Cord, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: less of patients enrolled). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of neurological deficits caused by spinal cord lesions (time frame: Change from baseline-admission scores ( ASIA ) at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03101982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in