A Phase 3 interventional study of Inhaled Nitric Oxide and Placebo in Traumatic Brain Injury, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by University of Cincinnati · Phase 3, Interventional, and Treatment
Among 907 studies in Brain Injuries, Traumatic with a site in United States — 210 open to participants now, 247 under way, 5 of them phase 3. Brain Injuries, Traumatic · United States.
Among the 907 studies in Brain Injuries, Traumatic with a site in United States, this one is the 538th largest by enrollment of the 648 interventional ones that give a count, is one of 51 that started in 2018, is one of 26 in phase 3, and was the 449th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
Browse Brain Injuries, Traumatic studies →210 of the 907 studies in Brain Injuries, Traumatic with a site in United States are open now. Recruiting first, the newest first:
Andrew Mayer · Sites in United States
Ages 18–82 · Healthy volunteers
Columbia University · Sites in United States
Ages 18+
Columbia University · Sites in United States, Brazil, Canada and 2 more countries
Ages 18+
University of Michigan · Sites in United States
Ages 18–65
University of Michigan · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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907 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 65 · Phase 2 110 · Phase 3 39 · Phase 4 28
First in 1996; this study’s year is marked. 51 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Median enrollment 50 across the 648 interventional studies, 120 across the 257 observational. Of the 553 that completed or were terminated, 182 (33%) have results posted.
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101 of 907 have an industry lead sponsor. The 10 most frequent:
University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
University of Cincinnati has 9 studies filed under Brain Injuries, Traumatic — fewer than ten, so there is no comparison to draw.
82 of the studies in Brain Injuries, Traumatic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06368648CoMind Technologies LimitedCoMind Early Feasibility Study | 2026-11 |
| NCT06103201University of Maryland, BaltimoreHyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury | 2026-11-26 |
| NCT07733284Kessler FoundationHome-Based Walking for Thinking Skills in Persons With TBI | 2026-12 |
| NCT06228391Minneapolis Veterans Affairs Medical CenterKetamine Treatment for PTSD and MDD in TBI | 2026-12 |
| NCT05702138Craig HospitalHigh Intensity Step Training After Traumatic Brain Injury | 2026-12 |
Add all 82 to your calendar (.ics) → With an account.
Among the 907 studies in Brain Injuries, Traumatic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate the changes in respiratory mechanics following traumatic brain injury and determine the effect of inhaled nitric oxide on gas exchange.
Intubation and mechanical ventilation are common treatments in the care of patients with traumatic brain injury (TBI). Intubation allows for airway control and facilitates removal of respiratory secretions. Mechanical ventilation allows control of arterial carbon dioxide to aid in control of intracranial pressure. Recent evidence suggests that lung protective ventilation (tidal volumes of 6 ml/kg of predicted body weight and moderate positive end expiratory pressure) improves outcomes following brain injury and reduces brain-lung cross talk.
The treatment of respiratory failure in TBI must balance the need to improve lung function with the negative consequences of increased intrathoracic pressure on mean arterial pressure, intracranial pressure and venous return. Traditional treatment of increasing positive end expiratory (PEEP) and mean airway pressure then, represent competing interests. Methods for improving arterial oxygenation while avoiding negative hemodynamic effects are needed.
The impact of head injury on respiratory mechanics has been studied in just a few clinical investigations. (1-3) Of note, the earliest of these noted that the ventilation perfusion (V/Q) matching following TBI was not the result of lung collapse or parenchymal lung disease but secondary to alterations in perfusion. There are three possibilities for this finding:
The introduction of inhaled pulmonary vasodilators such as inhaled nitric oxide or aerosolized epoprostenol offer an opportunity to improve oxygenation in patients with TBI without increasing airway pressures in the face of V/Q inequalities.
This study will evaluate the changes in respiratory mechanics following TBI and determine the effect of inhaled nitric oxide on gas exchange.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Inhaled nitric oxide at 20 parts per million, administered once during first 36 hours following admission
Drug: Inhaled Nitric Oxide
Nitrogen only, administered once during first 36 hours following admission
Drug: Placebo
Patients randomized to this arm will receive inhaled nitric oxide 20 parts per million.
Nitrogen plus oxygen
PaO2
The primary endpoint is the difference in PO2
Time frame: at Day 3 of the study
| Milestone | in Haled Nitric Oxide | Placebo |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
The primary endpoint is the difference in PO2
| mmHg | Inhaled Nitric Oxide | Placebo |
|---|---|---|
| PaO2 | 115 ± 10 | 95 ± 10 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inhaled Nitric Oxide | 3/6 (50%) | 0/6 (0%) | 0/6 (0%) |
| Placebo | 2/7 (28.6%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Inhaled Nitric Oxide | Placebo | Total |
|---|---|---|---|
| Mean | 63 ± 17 | 49 ± 20 | 53 ± 18 |
| Sex: Female, Male(Participants) | Inhaled Nitric Oxide | Placebo | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 5 | 3 | 8 |
| Race (NIH/OMB)(Participants) | Inhaled Nitric Oxide | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 7 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Inhaled Nitric Oxide | Placebo | Total |
|---|---|---|---|
| United States | 6 | 7 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2018 to primary completion in Dec 2023, 60 months.
Results were first posted in Apr 2025, 1 year 4 months after primary completion.
Of 30 phase 3 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 69. This study's 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitric Oxide