Overview

The Trial to Reduce Off-Label use of ECMO in Youth (TROLLEY) is an FDA-regulated, multicenter, randomized controlled trial of 50 patients. The primary purpose of this study is to evaluate the safety and effectiveness of the Cardiohelp System to provide up to 30 days of circulatory support in children with cardiac failure. The secondary purpose is to evaluate the safety and effectiveness of heparin vs. bivalirudin as the primary blood thinner for children on ECMO who are supported with the Cardiohelp system.

Extracorporeal Oxygenation Membrane (ECMO) circuit. Blood is pumped from the heart outside the body, through venous drainage though a pump connected with a pump console. The blood is then re-oxygenated as it is pumped through a membrane oxygenator connected to a gas mixture, and passes through arterial return back to the heart.
A complete ECMO circuit. Blood is pumped outside of the body through mechanical components and back to the lungs and heart.