Early normobaric hyperoxia for traumatic cervical or thoracic spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IIa, single-center, open-label trial delivers intermittent normobaric hyperoxia (FiO2 100%) to mechanically ventilated adults with acute cervical or thoracic traumatic spinal cord injury. Participants receive two 4.5-hour oxygen sessions per day for five consecutive days, with one session pair separated by a minimum 90 minutes and the other by about 10 hours. Eligible patients are adults (18–85) with AIS grades A–C who are awake, can follow commands, have baseline PaO2 >80 mmHg, and can start treatment within 24 hours of injury, while those with traumatic brain injury are excluded. The trial collects biomarker and clinical safety signals to see if this dosing schedule appears promising for reducing secondary injury.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Daryl Fields, MD, PhD — University of Florida
• Study coordinator: Andrew Kline
• Email: andrew.kline@neurosurgery.ufl.edu
• Phone: 352-273-9000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.