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

NCT03101982 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-05-09

No results posted yet for this study

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. 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.

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).

Conditions

  • Traumatic Injury of the Spinal Cord

Interventions

DRUG

HBO

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

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03101982 on ClinicalTrials.gov