EDC For Mid-Study Changes In Medical Device Clinical Trials

Heart transplants have always had a limited shelf life. A retrieved heart can move only so far from a donor to a recipient, and the distance depends on how long human tissue can survive without blood flow. Ice helps, but the less time outside a body, the better.

A medical device manufacturer, who we’ll call Company X, had an innovative idea: what if we perfused the heart (that is, kept it oxygenated) while moving it from the donor to the recipient? They developed a solution that fed oxygenated blood to the heart as it was in transit and awaiting a donor.

Successful premarket tests with animal hearts allowed Company X and AKRN Scientific Consulting, a contract research organization based in Madrid, Spain, to expect positive results from clinical research.

The clinical study would ask the question, “Would non-ischemic heart preservation prolong organ function in an adult heart transplant patient?” But designing a clinical study to test this innovative transportation solution was complex: the study must incorporate real-time feedback while maintaining consistent protocol amendments. Those two needs pointed to using an electronic data capture (EDC) system that is quick to adapt and easy to scale as the study changed. That is precisely where Castor came in.