Normobaric Hyperoxia for Spinal Cord Injury

(SpiCoH Trial)

Overseen By Ralisa Pop

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Disqualifiers: Traumatic brain injury, Hypoxia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Daryl Fields, MD, PhD

Principal Investigator

University of Florida

Carolina Maciel, MD, MSCR

Principal Investigator

University of Florida

Katharina Busl, MD, MS

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Inclusion Criteria

Stated willingness to comply with all study procedures for the duration of the study

Need for mechanical ventilation (MV), as determined by the treating physician

I am between 18 and 85 years old.

Exclusion Criteria

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

Participation in a concurrent investigational/interventional study (observational studies allowed)

Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

24 hours

Treatment

Intermittent normobaric hyperoxia therapy administered twice daily for 5 consecutive days

5 days

Daily in-person visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Normobaric Hyperoxia

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Normobaric hyperoxia

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+