RecruitingTraumatic Spinal Cord Injuries

Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Eligible age

18–85 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: University of Florida

You may qualify if…

✓ 1. Provision of signed and dated ICF by the subject or LAR
✓ 2. Stated willingness to comply with all study procedures for the duration of the study
✓ 3. Male or female subjects, aged ≥18 and ≤ 85 years
✓ 4. Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)
✓ 5. Awake and able to interact and follow commands
✓ 6. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C
✓ 7. Need for mechanical ventilation (MV), as determined by the treating physician
✓ 8. Baseline PaO2 \>80 mmHg before enrollment

You may not qualify if…

✕ 1. 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
✕ 2. AIS grades D or E at time of arrival to hospital
✕ 3. Persistent hypoxia requiring \>40% FiO2 to maintain PaO2 \>80 mmHg
✕ 4. 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)
✕ 5. Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes
✕ 6. Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery
✕ 7. Participation in a concurrent investigational/interventional study (observational studies allowed)
✕ 8. Known to be pregnant, or with a positive pregnancy test

Where it's recruiting

Florida

Gainesville

Source: ClinicalTrials.gov · NCT07465302 · last updated 2026-05-01