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

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ClinicalTrials.gov Identifier: NCT03101982
Recruitment Status : Not yet recruiting
First Posted : April 5, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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).


Condition or disease Intervention/treatment Phase
Traumatic Injury of the Spinal Cord Drug: HBO Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: test
HBO, ASIA score, blood taking
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.
Other Name: Hyperbaric oxygenation

No Intervention: control
ASIA score, blood taking



Primary Outcome Measures :
  1. Improvement of neurological deficits caused by spinal cord lesions [ Time Frame: Change from baseline-admission scores ( ASIA ) at 12 months ]
    assessed by American Spinal Injury Association (ASIA) scores

  2. Correlation of clinical observations with blood parameters [ Time Frame: 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 ]
    assessed by routinely taken blood tests



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

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
  • 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

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03101982     History of Changes
Other Study ID Numbers: HBOwings
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System