NCT07465302 Treating Spinal Cord Injury With Early Normobaric Hyperoxia
| NCT ID | NCT07465302 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Florida |
| Condition | Traumatic Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2026-04-15 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 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 9. Capacity to initiate the study intervention within 24 hours of injury Exclusion Criteria: 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 9. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB) 10. Patient has any other clinically significant medical condition as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results
Contact & Investigator
Carolina Maciel, MD, MSCR
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT07465302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Traumatic Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07465302 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07465302 currently recruiting?
Yes, NCT07465302 is actively recruiting participants. Contact the research team at andrew.kline@neurosurgery.ufl.edu for enrollment information.
Where is the NCT07465302 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT07465302 clinical trial?
NCT07465302 is sponsored by University of Florida. The principal investigator is Carolina Maciel, MD, MSCR at University of Florida. The trial plans to enroll 12 participants.