At a glance
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A Randomised Controlled Trial of Nitric Oxide Administration During Cardiopulmonary Bypass in Infants Undergoing Arterial Switch Operation for Repair of Transposition of the Great Arteries
In Brief
A Phase 3 clinical trial evaluating Nitric Oxide for Low Cardiac Output Syndrome and Transposition of Great Vessels. Completed, enrolled 300 participants across 4 sites in 4 countries.
Detailed Summary
This trial will test if adding nitric oxide (NO) gas to the cardiopulmonary bypass (CPB) circuit in infants undergoing an arterial switch operation (ASO) for Transposition of the Great Arteries (TGA) changes the incidence of major postoperative adverse events (AEs). Major postoperative AEs include cardiac arrest, emergency chest opening, use of ECMO (machine that acts as an artificial heart and lung during surgery), and death. Participants will be randomised to receive oxygen plus nitric oxide (intervention arm) or oxygen without nitric oxide (control arm) during CPB.
Study Details
Timeline
Interventions
Addition of nitric oxide 20ppm into bypass circuit