Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury (NCT05616910) | Clinical Trial Compass
By InvitationPhase 2
Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury
United States38 participantsStarted 2025-04-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18-75 (inclusive)
. GCS 9-12 or GCS 13-15 with an abnormal imaging scan
. Radiologic findings indicative of primarily diffuse TBI
Exclusion criteria
. Severe cardiac dysfunction (e.g. elevation of pulmonary edema on chest xray, large elevation of cardiac enzymes)
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in relatively early testing — can you explain what that means for how much is already known about the safety and effectiveness of inhaled nitric oxide specifically for traumatic brain injury?
2The trial is measuring cerebral metabolism using spectroscopy — can you help me understand what that means in practice, and what researchers are hoping to see change in the brain as a result of the inhaled nitric oxide treatment?
3The study is enrolling by invitation only — what would need to be true about my situation or my loved one's injury for a doctor to consider referring someone to this trial, and is that something worth exploring with the treating team?
4Nitric oxide affects blood vessels and blood flow — are there any specific risks or side effects I should ask about that might be especially relevant given the nature of a traumatic brain injury?
5Before considering a trial like this, are there standard treatments for microvascular dysfunction after traumatic brain injury that should be tried first, or is this type of research being offered because standard options are limited?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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