Traumatic Spinal Cord Injuries
Conditions
Keywords
normobaric hyperoxia, hyperoxia, biomarkers, traumatic spinal cord injury, FiO2 100%
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.
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.
Interventions
OTHERNormobaric Hyperoxia
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.
Sponsors
University of Florida
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of early normobaric hyperoxic therapy | 24 hours from injury | Proportion of subjects receiving first normobaric hyperoxia therapy. |
| Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically | From enrollment to the end of intervention period at 5 days | Serial PaO2 |
| Preliminary safety of intermittent normobaric hyperoxia | From completion of first treatment to end of 6 month follow up period | Four-point end-organ toxicity surveillance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration | From enrollment to the end of intervention period at 5 days | Serial PaO2. Proportion of subjects receiving all 10 planned normobaric hyperoxia treatments. |
| Exploratory safety objectives | From enrollment to end of 6 month follow up period | Rates of study termination from demonstrated signs of organ injury attributable to hyperoxia determined by safety monitoring board |
| Feasibility - Timely Placement of Lumbar Drain | Time of injury to 24hr post injury. | Proportion of subjects with lumbar drain placed before initiation of normobaric hyperoxia. |
| Feasibility - Completion of Required Monitoring Lines | Day 0 to day 5 | Proportion of subjects with lumbar drain and arterial line for the duration of 5-day intervention period. |
| Protocol Adherence - Sampling Deviations | Enrollment to end of 6 month follow up period | Rate of protocol violations or deviations related to missing samples or samples obtained outside the planned schedule for blood and/or CSF. |
| Sample Handling - Discarded Specimens | From enrollment to end of 6 month follow up period | Rate of discarded CSF or blood samples |
Contacts
CONTACTAndrew Kline
CONTACTRalisa Pop
PRINCIPAL_INVESTIGATORCarolina Maciel, MD, MSCR
University of Florida
PRINCIPAL_INVESTIGATORKatharina Busl, MD, MS
University of Florida
PRINCIPAL_INVESTIGATORDaryl Fields, MD, PhD
University of Florida
Outcome results
None listed