Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study
Primary Purpose
Traumatic Injury of the Spinal Cord
Status
Recruiting
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
HBO
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Injury of the Spinal Cord
Eligibility 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
Sites / Locations
- Medical University GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
test
control
Arm Description
HBO, ASIA score, blood taking
ASIA score, blood taking
Outcomes
Primary Outcome Measures
Improvement of neurological deficits caused by spinal cord lesions
assessed by American Spinal Injury Association (ASIA) scores
Correlation of clinical observations with blood parameters
assessed by routinely taken blood tests
Secondary Outcome Measures
Full Information
NCT ID
NCT03101982
First Posted
March 22, 2017
Last Updated
March 14, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT03101982
Brief Title
Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study
Official Title
Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injury of the Spinal Cord
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test
Arm Type
Active Comparator
Arm Description
HBO, ASIA score, blood taking
Arm Title
control
Arm Type
No Intervention
Arm Description
ASIA score, blood taking
Intervention Type
Drug
Intervention Name(s)
HBO
Other Intervention Name(s)
Hyperbaric oxygenation
Intervention Description
Hyperbaric oxygenation (HBO) is defined as breathing of 100% oxygen under elevated ambient pressure in a hyperbaric chamber. HBO is considered a pharmacological therapy.
Primary Outcome Measure Information:
Title
Improvement of neurological deficits caused by spinal cord lesions
Description
assessed by American Spinal Injury Association (ASIA) scores
Time Frame
Change from baseline-admission scores ( ASIA ) at 12 months
Title
Correlation of clinical observations with blood parameters
Description
assessed by routinely taken blood tests
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Freyja Smolle-Jüttner
Phone
+43/316/ 385-13302
Email
freyja.smolle@medunigraz.at
Facility Information:
Facility Name
Medical University Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freyja Smolle-Jüttner
Phone
+43/316/ 385-13302
Email
freyja.smolle@medunigraz.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study
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