Inhaled Nitric Oxide for Stroke
(DOMINO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is a non-randomized, Phase 2 clinical trial designed to measure the cerebral blood flow (CBF) response to inhaled nitric oxide in acute ischemic stroke patients and healthy subjects. The monitoring is a 35 minute session during which cerebral hemodynamics will be monitored with both diffuse correlation spectroscopy (DCS) and transcranial doppler ultrasonography (TCD) while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide (NO)/nitrogen dioxide (NO2) concentration, are continuously monitored.
Who Is on the Research Team?
Steven R Messe, M.D.
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monitoring
Participants undergo a 35-minute session to measure cerebral blood flow response to inhaled nitric oxide
Follow-up
Participants are monitored for tolerability issues or adverse events 24 hours after the monitoring session
What Are the Treatments Tested in This Trial?
Interventions
- Nitric Oxide
Nitric Oxide is already approved in United States for the following indications:
- Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension
- Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension
- Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Steven Messe
Lead Sponsor
Mallinckrodt
Industry Sponsor
Mario Saltarelli
Mallinckrodt
Chief Medical Officer
MD
Siggi Olafsson
Mallinckrodt
Chief Executive Officer
PhD in Pharmacy