What has been the safety experience with PolyHeme® in prior studies?
During the course of evaluation of any investigational product, both adverse experiences and serious adverse experiences can occur. These may be due to either the underlying condition of the patient, the treatment setting, or the investigational product itself. Both adverse experiences and serious adverse experiences have occurred in prior studies. PolyHeme® was studied in one trial in patients experiencing planned acute blood loss while undergoing elective surgery for abdominal aortic aneurysm. The trial included a non-routine procedure called acute normovolemic hemodilution (ANH) in which a large quantity of the patient’s own blood, up to 60%, is removed prior to the surgery, and is later replaced. The procedure in this study resulted in the infusion of large volumes of blood in addition to up to 6 units of PolyHeme® in the experimental group, while smaller overall volumes of blood alone were administered in the control group. Serious cardiovascular adverse experiences occurred more
