Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05616910
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • inhaled nitric oxide — DRUG
    iNO will be provided by ventilator or nasal cannula for 4 hours each day.

Study Details

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.

Key Dates

Start date
Apr 6, 2025
Status verified
May 2025
Primary completion
Mar 28, 2028
Completion
Mar 28, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group iNO
    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.
  • Sham Comparator: Group SRS
    Subjects will receive standard respiratory support (SRS) for 8 hours.

Primary Outcome Measure

Cerebral Metabolism assessed by Spectroscopy [ Time Frame: 4 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By research site
Penn Presbyterian Medical Center· Philadelphia, PA

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