Trial Outcomes & Findings for Inhaled Nitric Oxide in Brain Injury (NCT NCT03260569)

NCT ID: NCT03260569

Last Updated: 2025-04-30

Results Overview

The primary endpoint is the difference in PO2

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 13 participants
• Primary outcome timeframe: at Day 3 of the study
• Results posted on: 2025-04-30

Participant Flow

Participant milestones

Measure	in Haled Nitric Oxide received nitric oxide	Placebo did not receive iNO
Overall Study STARTED	6	7
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Nitric Oxide in Brain Injury

Baseline characteristics by cohort

Measure	Inhaled Nitric Oxide n=6 Participants received nitric oxide	Placebo n=7 Participants did not receive iNO	Total n=13 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 17 • n=5 Participants	49 years STANDARD_DEVIATION 20 • n=7 Participants	53 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: at Day 3 of the study

The primary endpoint is the difference in PO2

Outcome measures

Measure	Inhaled Nitric Oxide n=6 Participants Inhaled nitric oxide at 20 parts per million, administered once during first 36 hours following admission Inhaled Nitric Oxide: Patients randomized to this arm will receive inhaled nitric oxide 20 parts per million.	Placebo n=7 Participants Nitrogen only, administered once during first 36 hours following admission Placebo: Nitrogen plus oxygen
PaO2	115 mmHg Standard Deviation 10	95 mmHg Standard Deviation 10

Adverse Events

Inhaled Nitric Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Goodman

University of Cincinnati

Phone: 5135585661

Email: michael.goodman@uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place