Traumatic Spinal Cord InjuriesPhase 2SpiCoHNCT07465302
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
A Phase 2 study testing Normobaric Hyperoxia in people with Traumatic Spinal Cord Injuries, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traumatic Spinal Cord Injuries
- What is being tested?
- Normobaric Hyperoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Awake and able to interact and follow commands
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C
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- Need for mechanical ventilation (MV), as determined by the treating physician
- Baseline PaO2 >80 mmHg before enrollment
- Capacity to initiate the study intervention within 24 hours of injury
Who cannot join
- 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)
- Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes
- Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery
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- Participation in a concurrent investigational/interventional study (observational studies allowed)
- Known to be pregnant, or with a positive pregnancy test
- Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Andrew Kline, 724-496-8034, andrew.kline@ufl.edu
About this study
Official title: Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility 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.
Read the detailed description
Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.
- Conditions
- Traumatic Spinal Cord Injuries
- Being tested
- Normobaric Hyperoxia
- Keywords
- normobaric hyperoxia, hyperoxia, biomarkers, traumatic spinal cord injury, FiO2 100%
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric HyperoxiaOther
Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Normobaric hyperoxia Receives: Other: Normobaric Hyperoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of early normobaric hyperoxic therapy
Proportion of subjects receiving first normobaric hyperoxia therapy.
Measured: 24 hours from injury
Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically
Serial PaO2
Measured: From enrollment to the end of intervention period at 5 days
Preliminary safety of intermittent normobaric hyperoxia
Four-point end-organ toxicity surveillance.
Measured: From completion of first treatment to end of 6 month follow up period
Secondary outcomes (6)
Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration
Serial PaO2. Proportion of subjects receiving all 10 planned normobaric hyperoxia treatments.
Measured: From enrollment to the end of intervention period at 5 days
Exploratory safety objectives
Rates of study termination from demonstrated signs of organ injury attributable to hyperoxia determined by safety monitoring board
Measured: From enrollment to end of 6 month follow up period
Feasibility - Timely Placement of Lumbar Drain
Proportion of subjects with lumbar drain placed before initiation of normobaric hyperoxia.
Measured: Time of injury to 24hr post injury.
Feasibility - Completion of Required Monitoring Lines
Proportion of subjects with lumbar drain and arterial line for the duration of 5-day intervention period.
Measured: Day 0 to day 5
Protocol Adherence - Sampling Deviations
Rate of protocol violations or deviations related to missing samples or samples obtained outside the planned schedule for blood and/or CSF.
Measured: Enrollment to end of 6 month follow up period
Sample Handling - Discarded Specimens
Rate of discarded CSF or blood samples
Measured: From enrollment to end of 6 month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start15 Apr 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Carolina Maciel, MD, MSCR, Principal investigator, University of FloridaKatharina Busl, MD, MS, Principal investigator, University of FloridaDaryl Fields, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465302
- Sponsor's protocol ID
- IRB202400873
- Other IDs
- 4R00GM159353-02
- Acronym
- SpiCoH
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the primary results of this study-including de-identified clinical, physiologic, and outcome variables-will be made available following publication of the main results. Data will be shared in accordance with institutional policies and applicable regulations after all direct identifiers have been removed using a standardized de-identification protocol. The curated dataset, accompanying data dictionary, and analytic code (when applicable) will be deposited in the National Spinal Cord Injury Statistical Center (https://sites.uab.edu/nscisc/), where they will be accessible under a controlled-access model. Qualified researchers may request access by submitting a brief proposal outlining the intended use of the data; requests will be reviewed by the study team to ensure scientific validity and compliance with participant privacy protections. Data will remain available for the duration required by institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
- ClinicalTrials.gov ID
- NCT07465302
- Acronym / sponsor ID
- SpiCoH / IRB202400873
- Conditions
- Traumatic Spinal Cord Injuries
- Keywords
- normobaric hyperoxia, hyperoxia, biomarkers, traumatic spinal cord injury, FiO2 100%
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Normobaric HyperoxiaNormobaric hyperoxia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- Awake and able to interact and follow commands
Key exclusion criteria (10 listed)
- 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)
- Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normobaric HyperoxiaIntermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A. | Other | Intervention |
Primary outcome
Feasibility of early normobaric hyperoxic therapy
Time frame: 24 hours from injury
Proportion of subjects receiving first normobaric hyperoxia therapy.
Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically
Time frame: From enrollment to the end of intervention period at 5 days
Serial PaO2
Preliminary safety of intermittent normobaric hyperoxia
Time frame: From completion of first treatment to end of 6 month follow up period
Four-point end-organ toxicity surveillance.
6 secondary outcomes
Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration
Time frame: From enrollment to the end of intervention period at 5 days
Exploratory safety objectives
Time frame: From enrollment to end of 6 month follow up period
Feasibility - Timely Placement of Lumbar Drain
Time frame: Time of injury to 24hr post injury.
Feasibility - Completion of Required Monitoring Lines
Time frame: Day 0 to day 5
Protocol Adherence - Sampling Deviations
Time frame: Enrollment to end of 6 month follow up period
Sample Handling - Discarded Specimens
Time frame: From enrollment to end of 6 month follow up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the primary results of this study-including de-identified clinical, physiologic, and outcome variables-will be made available following publication of the main results. Data will be shared in accordance with institutional policies and applicable regulations after all direct identifiers have been removed using a standardized de-identification protocol. The curated dataset, accompanying data dictionary, and analytic code (when applicable) will be deposited in the National Spinal Cord Injury Statistical Center (https://sites.uab.edu/nscisc/), where they will be accessible under a controlled-access model. Qualified researchers may request access by submitting a brief proposal outlining the intended use of the data; requests will be reviewed by the study team to ensure scientific validity and compliance with participant privacy protections. Data will remain available for the duration required by institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Maciel, MD, MSCR principal investigator
University of Florida
Katharina Busl, MD, MS principal investigator
University of Florida
Daryl Fields, MD, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normobaric Hyperoxia in people with Traumatic Spinal Cord Injuries, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Kline (352-273-9000, andrew.kline@neurosurgery.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of early normobaric hyperoxic therapy (time frame: 24 hours from injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.