Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07465302
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07465302
Study Brief:
Protocol Section:
NCT07465302