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New treatment option for Traumatic Spinal Cord Injuries
Official title Treating Spinal Cord Injury With Early Normobaric Hyperoxia
ClinicalTrials.gov ID: NCT07465302
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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 people, 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
You likely can't join if
- Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural...
- 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...
- Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or...
- Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery
See the full eligibility criteria
- 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 people, 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
- 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
- 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...
- 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...
- 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
- Participation in a concurrent investigational/treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.