E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We want to investigate the effect of hyperbaric oxygen therapy on the neurological and clinical outcome following traumatic injury of the spinal cord. |
Wir möchten den Einfluss von unter Überdruckbedingungen eingeatmeten Sauerstoff auf das neurologische und klinische Outcome nach traumatischen Rückenmarksverletzungen untersuchen. |
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E.1.1.1 | Medical condition in easily understood language |
Traumatic injury of the column is most often associated with damage to the spinal cord, leading to peripheral neurological deficits as paralysis and numbness. |
Traumatische Verletzungen der Wirbelsäule führen oftmals zu Schäden des Rückenmarks, wodurch es zu peripheren neurologischen Schäden wie Lähmungen und Taubheit kommt. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Biological Phenomena [G16] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
We aim at testing the hypothesis that hyperbaric oxygen therapy (HBO- therapy) leads to an improvement of neurological deficits caused by spinal cord lesions. Furthermore, we want to correlate the clinical observations with blood parameters from routinely taken blood tests. |
Wir zielen darauf ab, die Hypothese zu bestätigen, dass hyperbare Sauerstofftherapie (HBO-Therapie) zu einer Verbesserung der neurologischen Defizite nach traumatischen Rückenmarksverletzungen führt. Weiteres wollen wir anhand von routinemäßig entnommenen Blutproben die klinischen Beobachtungen mit Blutparametern korrelieren. |
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E.2.2 | Secondary objectives of the trial |
Not applicable. |
Nicht zutreffend |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 16 - 70 years Traumatic spinal cord injury Vertebral column stable No significant compression of spinal cord Circumstances allowing HBO to be started within 24 h following trauma |
Alter 16 - 70 Jahre Traumatische Rückenmarksverletzungen Stabile Wirbelsäule Keine signifikante Kompression des Rückenmarks Umstände, die Beginn der HBO-Therapie binnen 24 Stunden erlauben |
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E.4 | Principal exclusion criteria |
Morphologically confirmed complete discontinuation of spinal cord Cardiorespiratory instability Cystic/bullous lung disease Untreated pneumothorax Pregnancy Sepsis, SIRS Treatment with doxorubicin in patient's history
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Kardiorespiratorische Instabilität Zystische/bullöse Lungenerkrankung Unbehandelter Pneumothorax Schwangerschaft Sepsis, SIRS Frühere Behandlung mit Doxorubicin |
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of hyperbaric oxygen therapy on recovery and outcome following spinal cord injury.
Comparison of clinical, radiological and neurological outcome with molecular blood markers. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After all 21 HBO-sessions have been completed (and blood results from last blood test have been analysed. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Keine HBO Therapie verabreicht |
No HBO therapy administered |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |