Pediatric HD Clinical Trial
Official title:
EXCOR® Pediatric VAD Anticoagulation IDE Investigational Plan
The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge
to transplantation for children in 2011. Successful bridge to transplantation or recovery in
the IDE trial of the Berlin Heart EXCOR was 88% to 92%, but a high incidence of neurological
injury was reported in this trial (29%).
Stroke remains the most important complication of Berlin Heart EXCOR support, with high
mortality rates, and considerable longāterm morbidity. The EXCOR IDE study incorporated a
novel anticoagulation protocol (henceforth referred to as the Edmonton Anticoagulation
Protocol). The preponderance of ischemic strokes in this study raised the question of whether
the anticoagulation protocol was sufficiently intensive, as ischemic strokes in this setting
are virtually always thromboembolic phenomena. In response to these data and to the
experience at the investigator's institution, a novel anticoagulation protocol has been
devised for use with the EXCOR (Stanford anticoagulation protocol).The purpose of this study
is to perform a pilot evaluation of this protocol in a multi--center setting, to prepare for
a randomized trial between this and a subsequent iteration of anticoagulation treatment.
n/a
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