Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03101982
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2017-03-22
Brief Title:
Hyperbaric Oxygenation HBO in Traumatic Spinal Cord Injury EOS - Pilot Study
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Hyperbaric Oxygenation HBO in Traumatic Spinal Cord Injury EOS - Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis of the Study
Based on the presented results the investigator hypothesises that HBO preserves neurons that are not irreversibly damaged ie 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 markersneuro-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
Based on the presented results the investigator hypothesises that HBO preserves neurons that are not irreversibly damaged ie 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 markersneuro-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None