Treating Spinal Cord Injury With Early Normobaric Hyperoxia
ConditionTraumatic Spinal Cord Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida
About this trial
SpiCoH is a phase IIa, single center, open-label, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and/or thoracic spinal cord injury.
Eligibility criteria
Qualifiers
Provision of signed and dated ICF by the subject or LAR
Stated willingness to comply with all study procedures for the duration of the study
Male or female subjects, aged ≥18 and ≤ 85 years
Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)
Disqualifiers
Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial hemorrhage, parenchymal contusions, and blunt cerebrovascular injury grades II-V
AIS grades D or E at time of arrival to hospital
Persistent hypoxia requiring >40% FiO2 to maintain PaO2 >80 mmHg
Concurrent injuries contraindicating lumbar drain placement, including, but not limited to: signs of infection at insertion site, elevated intracranial pressure, supratentorial mass lesion with mass effect, posterior fossa mass or uncorrected coagulopathy (thrombocytopenia <100,000/μL or International Normalized Ratio >1.5)
Trial design
Treatments tested in this trial
- Normobaric Hyperoxia
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Florida
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov