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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Inflammation, Platelet Dysfunction

In brief

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.

Key facts

Study ID

NCT03455218

Run by

Medical College of Wisconsin

People needed

40

Starts

2018-04-25

Expected to finish

2019-05-05

Last updated by the study team

2020-08-13

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants less than one year of age
• Undergoing cardiac surgery with the use of cardiopulmonary bypass

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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