Could extra oxygen help heal spinal cord injuries?
NCT ID NCT07465302
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving extra oxygen early after a spinal cord injury can help recovery. It involves 12 adults with recent traumatic spinal cord injuries who are on a breathing machine. The goal is to see if this treatment is safe and feasible, and if it improves oxygen levels in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States
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