NCT05616910

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
23mo left

Started Apr 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Apr 2025Mar 2028

First Submitted

Initial submission to the registry

October 31, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2.4 years until next milestone

Study Start

First participant enrolled

April 6, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2028

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

October 31, 2022

Last Update Submit

May 28, 2025

Conditions

Traumatic Brain Injury

Keywords

hypoperfusioncerebral blood flownitric oxidetraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Cerebral Metabolism assessed by Spectroscopy

    Metabolic Rate of oxygen consumption by the brain measured by diffuse correlation spectroscopy and time-resolved infrared-spectroscopy.

    4 days

Secondary Outcomes (5)

  • Incidence of Inhaled Nitric Oxide induced methemoglobinemia

    4 days

  • Incidence of Inhaled Nitric Oxide induced hypotension

    4 days

  • Incidence of Inhaled Nitric Oxide induced neurological deterioration

    4 days

  • Blood-based biomarkers of injury

    4 days, 6 months

  • Long term functional outcome

    6 months

Study Arms (2)

Group iNO

EXPERIMENTAL

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.

Drug: inhaled nitric oxide

Group SRS

SHAM COMPARATOR

Subjects will receive standard respiratory support (SRS) for 8 hours.

Drug: inhaled nitric oxide

Interventions

inhaled nitric oxideDRUG

iNO will be provided by ventilator or nasal cannula for 4 hours each day.

Also known as: standard respiratory therapy vs iNO
Group SRSGroup iNO

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Samuel Shin

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 15, 2022

Study Start

April 6, 2025

Primary Completion (Estimated)

March 28, 2028

Study Completion (Estimated)

March 28, 2028

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)