ZymoGenetics, Inc. (NASDAQ:ZGEN), announced today the submission of a Citizen Petition to the U.S. Food and Drug Administration (FDA) requesting that the FDA remove Thrombin-JMI® Thrombin, topical (bovine origin) from the market in the interest of patient safety. The Citizen Petition is prompted by recent reports of serious or fatal bleeding-related adverse events in surgical patients exposed to bovine (cattle-derived) thrombin.
Our data show that metabolic acidosis (increased strong ion gap) is associated with plasma concentration of heparan sulfate, a negatively charged glycosaminoglycan cleaved from the endothelial glycocalyx during cardiopulmonary bypass. In addition, cleavage of heparan sulfate was associated with renal dysfunction, capillary leak, and global markers of cardiovascular dysfunction. These data highlight the importance of designing translational therapies to protect the glycocalyx in cardiopulmonary bypass.