Inhaled Nitric Oxide for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen by Samuel Shin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Traumatic brain injury (TBI) causes acute deficits in cerebral perfusion which may lead to secondary injury and worse outcomes. Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults. The investigators will perform a randomized controlled trial of iNO treatment in TBI patients acutely after injury. The investigators will then assess perfusion changes with optic neuromonitoring, blood biomarkers, and 6 month clinical outcomes.

Eligibility Criteria

Adults aged 18-75 with moderate traumatic brain injury (TBI), evidenced by specific criteria such as post-traumatic amnesia, loss of consciousness for a certain time, and particular radiologic findings. Patients both on breathing support and not are included. Excluded are those with severe heart issues, known large vessel brain disease, lung conditions like ARDS or pulmonary hypertension, serious kidney disease, immediate need for brain surgery, or pre-existing major psychiatric/neurological disorders.

Inclusion Criteria

I experienced memory loss for a day after an injury.

Loss of consciousness for 30 minutes to 24 hours

Radiologic findings indicative of primarily diffuse TBI

Exclusion Criteria

I do not have severe heart problems.

I currently have a respiratory infection.

I have a large brain bleed.

Participant Groups

The trial is testing inhaled nitric oxide (iNO), a gas that widens blood vessels to improve blood flow in the brain after TBI. Participants will be randomly assigned to receive iNO soon after their injury. The study will monitor changes in blood flow using optic neuromonitoring and measure recovery outcomes up to six months later.

Group I: Group B Experimental Treatment 1 Intervention

Subjects will receive iNO for 4 hours, followed by standard respiratory support (SRS) for 4 hours. This pattern will be reversed the next day (SRS then iNO). on the following day, the pattern will be reversed back to iNO for 4 hours and SRS for 4 hrs.

Group II: Group A Experimental Treatment 1 Intervention

Subjects will receive iNO for 4 hours, followed by standard respiratory support (SRS) for 4 hours. This pattern will be reversed the next day (SRS then iNO). on the following day, the pattern will be reversed back to iNO for 4 hours and SRS for 4 hrs.

Inhaled Nitric Oxide is already approved in United States, United States, European Union for the following indications:

🇺🇸 Approved in United States as INOmax for:

• Hypoxic respiratory failure
• Pulmonary hypertension

🇺🇸 Approved in United States as Genosyl for:

• Hypoxic respiratory failure
• Pulmonary hypertension

🇪🇺 Approved in European Union as INOmax for:

• Persistent pulmonary hypertension of the newborn
• Acute hypoxic respiratory failure

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Penn Presbyterian Medical Center Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania Lead Sponsor

References