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Vasodilator

Inhaled Nitric Oxide for Stroke (DOMINO Trial)

Phase 2
Waitlist Available
Led By Steven R Messe, M.D.
Research Sponsored by Steven Messe
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stroke Patients: Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain
Stroke Patients: Age greater than 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up conclusion of the 35 minute protocol
Awards & highlights

DOMINO Trial Summary

This trial is measuring the cerebral blood flow response to inhaled nitric oxide in acute ischemic stroke patients and healthy subjects.

Who is the study for?
This trial is for adults over 18 who've had a stroke in certain areas of the brain and can start the study within 72 hours of their stroke symptoms starting. They must be able to understand and agree to participate by signing an informed consent.Check my eligibility
What is being tested?
The trial tests how breathing in nitric oxide affects blood flow in the brain after a stroke, using special monitoring techniques like DCS and TCD during a single 35-minute session.See study design
What are the potential side effects?
Inhaling nitric oxide may cause side effects such as headaches, dizziness, or changes in blood pressure. Continuous monitoring will help track any immediate reactions.

DOMINO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke affecting the front, middle, or back part of my brain.
Select...
I am over 18 and have had a stroke.
Select...
I am over 18 years old.

DOMINO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~conclusion of the 35 minute protocol
This trial's timeline: 3 weeks for screening, Varies for treatment, and conclusion of the 35 minute protocol for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cerebral blood flow during the administration of iNO
Secondary outcome measures
Change in blood flow velocity as measured by TCD during iNO administration
Change in mean arterial blood pressure (MAP) during iNO administration
Duration of residual effect after cessation of iNO (time to return to baseline)
+1 more

DOMINO Trial Design

2Treatment groups
Experimental Treatment
Group I: Healthy ControlsExperimental Treatment1 Intervention
The protocol will be a 35-minute monitoring session, during which cerebral hemodynamics will be monitored with both DCS and TCD, while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide concentration, are continuously monitored. 5 minutes of baseline hemodynamics will be assessed, after which the subject will breath iNO for 5 minutes, followed by 5 minutes of room air. This iNO/room air cycle will be repeated with a total of 3 different iNO concentrations. The full protocol will require 35 minutes. Subjects will be called at 24 hours after the monitoring session to determine any tolerability issues or adverse events.
Group II: Acute Ischemic StrokeExperimental Treatment1 Intervention
Patients will be enrolled in the study within 72 hours of stroke symptom onset. The protocol will be a 35-minute monitoring session, during which cerebral hemodynamics will be monitored with both DCS and TCD, while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide concentration, are continuously monitored. 5 minutes of baseline hemodynamics will be assessed, after which the subject will breath iNO for 5 minutes, followed by 5 minutes of room air. This iNO/room air cycle will be repeated with a total of 3 different iNO concentrations. The full protocol will require 35 minutes. Subjects will be undergo a final assessment at 24 hours after the monitoring session to determine any tolerability issues or adverse events.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
2004
Completed Phase 4
~1280

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Who is running the clinical trial?

Steven MesseLead Sponsor
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,188 Total Patients Enrolled
Steven R Messe, M.D.Principal InvestigatorUniversity of Pennsylvania
~5 spots leftby Jul 2025
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