Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation

• Status: Completed
• Trial end date: 2019-05-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborators: Blood Center of Wisconsin; Clinical & Translational Science Institute of Southeast Wisconsin; Mallinckrodt; Versiti
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Infants less than one year of age

• Undergoing cardiac surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

• Prior surgery requiring CPB within the same hospitalization

• Pre-operative need for extracorporeal membrane oxygenation or mechanical circulatory support

• Known hypersensitivity to nitric oxide

• Known hemostatic or thrombotic disorder that results in an altered transfusion/anticoagulation protocol