Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:30 AM
Study NCT ID:
NCT07465302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018496', 'term': 'Hyperoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of early normobaric hyperoxic therapy', 'timeFrame': '24 hours from injury', 'description': 'Proportion of subjects receiving first normobaric hyperoxia therapy.'}, {'measure': 'Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically', 'timeFrame': 'From enrollment to the end of intervention period at 5 days', 'description': 'Serial PaO2'}, {'measure': 'Preliminary safety of intermittent normobaric hyperoxia', 'timeFrame': 'From completion of first treatment to end of 6 month follow up period', 'description': 'Four-point end-organ toxicity surveillance.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration', 'timeFrame': 'From enrollment to the end of intervention period at 5 days', 'description': 'Serial PaO2. Proportion of subjects receiving all 10 planned normobaric hyperoxia treatments.'}, {'measure': 'Exploratory safety objectives', 'timeFrame': 'From enrollment to end of 6 month follow up period', 'description': 'Rates of study termination from demonstrated signs of organ injury attributable to hyperoxia determined by safety monitoring board'}, {'measure': 'Feasibility - Timely Placement of Lumbar Drain', 'timeFrame': 'Time of injury to 24hr post injury.', 'description': 'Proportion of subjects with lumbar drain placed before initiation of normobaric hyperoxia.'}, {'measure': 'Feasibility - Completion of Required Monitoring Lines', 'timeFrame': 'Day 0 to day 5', 'description': 'Proportion of subjects with lumbar drain and arterial line for the duration of 5-day intervention period.'}, {'measure': 'Protocol Adherence - Sampling Deviations', 'timeFrame': 'Enrollment to end of 6 month follow up period', 'description': 'Rate of protocol violations or deviations related to missing samples or samples obtained outside the planned schedule for blood and/or CSF.'}, {'measure': 'Sample Handling - Discarded Specimens', 'timeFrame': 'From enrollment to end of 6 month follow up period', 'description': 'Rate of discarded CSF or blood samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['normobaric hyperoxia', 'hyperoxia', 'biomarkers', 'traumatic spinal cord injury', 'FiO2 100%'], 'conditions': ['Traumatic Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated ICF by the subject or LAR\n2. Stated willingness to comply with all study procedures for the duration of the study\n3. Male or female subjects, aged ≥18 and ≤ 85 years\n4. Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)\n5. Awake and able to interact and follow commands\n6. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C\n7. Need for mechanical ventilation (MV), as determined by the treating physician\n8. Baseline PaO2 \\>80 mmHg before enrollment\n9. Capacity to initiate the study intervention within 24 hours of injury\n\nExclusion Criteria:\n\n1. 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\n2. AIS grades D or E at time of arrival to hospital\n3. Persistent hypoxia requiring \\>40% FiO2 to maintain PaO2 \\>80 mmHg\n4. 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)\n5. Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes\n6. Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery\n7. Participation in a concurrent investigational/interventional study (observational studies allowed)\n8. Known to be pregnant, or with a positive pregnancy test\n9. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)\n10. 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'}, 'identificationModule': {'nctId': 'NCT07465302', 'acronym': 'SpiCoH', 'briefTitle': 'Treating Spinal Cord Injury With Early Normobaric Hyperoxia', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial', 'orgStudyIdInfo': {'id': 'IRB202400873'}, 'secondaryIdInfos': [{'id': '4R00GM159353-02', 'link': 'https://reporter.nih.gov/quickSearch/4R00GM159353-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Normobaric hyperoxia', 'interventionNames': ['Other: Normobaric Hyperoxia']}], 'interventions': [{'name': 'Normobaric Hyperoxia', 'type': 'OTHER', '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrew Kline', 'role': 'CONTACT', 'email': 'andrew.kline@neurosurgery.ufl.edu', 'phone': '352-273-9000'}, {'name': 'Ralisa Pop', 'role': 'CONTACT', 'email': 'Ralisa.Pop@neurology.ufl.edu', 'phone': '(352) 294-5693'}], 'overallOfficials': [{'name': 'Carolina Maciel, MD, MSCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Katharina Busl, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Daryl Fields, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}