Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

Enrolling by invitation · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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 facts

Study ID

NCT05616910

Run by

University of Pennsylvania

People needed

38

Starts

2025-04-06

Expected to finish

2028-03-28

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-75 (inclusive)
• GCS 9-12 or GCS 13-15 with an abnormal imaging scan
• Radiologic findings indicative of primarily diffuse TBI

You may not qualify if…

• Severe cardiac dysfunction (e.g. elevation of pulmonary edema on chest xray, large elevation of cardiac enzymes)
• Large focal injury (subdural hematoma, epidural hematoma, intraparenchymal hematoma, >30mL aggregate volume).
• Need for immediate neurosurgical intervention
• Pre-existing disabling psychiatric or neurological disorders such as cortical stroke, brain tumor, disabling multiple sclerosis, dementia, and severe TBI
• Known intracranial vessel disease
• Acute Respiratory Distress Syndrome (ARDS) or pre-existing pulmonary hypertension
• Cardiopulmonary resuscitation or cardioversion at admission
• Chronic Kidney Disease (Glomerular Filtration Rate <60mL/min/1.73m2)
• Respiratory Infection
• Prisoners, patients in police custody, pregnant women
• Possible drug interactions (nitric oxide donors: prilocaine, sodium nitroprusside, nitroglycerin)

Where it is running

• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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