Clinical Trials Logo

Clinical Trial Summary

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 longā€term 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03702192
Study type Interventional
Source Stanford University
Contact
Status Withdrawn
Phase N/A
Start date November 2018
Completion date January 17, 2019

See also
  Status Clinical Trial Phase
Completed NCT04376762 - Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients Phase 4
Recruiting NCT05433155 - Nasotracheal Intubation With VL vs DL in Infants Trial N/A
Completed NCT04125550 - Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease Phase 4