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NCT05616910
Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 38
Sponsor: University of Pennsylvania
Location: United States
Summary
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
Inclusion Criteria:Age 18-75 (inclusive)Male or FemaleGCS 9-12 or GCS 13-15 with an abnormal imaging scanLoss of consciousness for 30 minutes to 24 hoursPost traumatic amnesia 1 dayRadiologic findings indicative of primarily diffuse TBIBoth Intubated and nonintubated patientsExclusion Criteria: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 interventionPre-existing disabling psychiatric or neurological disorders such as cortical stroke, brain tumor, disabling multiple sclerosis, dementia, and severe TBIKnown intracranial large vessel diseaseAcute Respiratory Distress Syndrome (ARDS) or pre-existing pulmonary hypertensionCardiopulmonary resuscitation or cardioversion at admissionTransfusion at admissionChronic Kidney Disease (Glomerular Filtration Rate 60mL/min/1.73m2)
Source: ClinicalTrials.gov (NCT05616910). StuddyBuddy aggregates publicly available trial information.