At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet activation-a Single Center Pilot Study
In Brief
A Phase 3 clinical trial evaluating Nitric Oxide, Placebo, and 1 other intervention for Inflammation and Platelet Dysfunction. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Open heart surgery requires the use of a cardiopulmonary bypass (CPB) circuit. As blood flows across the artificial surfaces of the CPB circuit, platelets are activated and consumed. This activation results in a profound inflammatory reaction and need for transfusion. This reaction is intensified in younger, smaller patients undergoing longer, more complex open heart surgery. Nitric oxide is naturally released by vascular endothelial surfaces and acts as a signaling molecule which prevents platelet activation. The investigators hypothesize that the addition of the nitric oxide to the sweep gas of the oxygenator during cardiopulmonary bypass surgery will replace this natural endothelial function and thus prevent platelet activation and consumption. The investigators plan to test this hypothesis with a pilot double blinded, randomized trial of 40 patients less than a year of age undergoing cardiac surgery requiring CPB.
Study Details
Timeline
Interventions
20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass
INOmax device connected to oxygenator, but no gas is delivered
All patients will have the INOmax device connected to the oxygenator