Questions About Strategies and Dosing Levels of PCC for Coagulopathic Bleeding in Cardiac Surgery—Reply
In Reply We thank the authors for their interest in the FARES-II study. In response to Dr González-Ruiz and colleagues, it is important to note that point-of-care INR testing was not used as a stand-alone test and that hemostatic therapy was not empirical. Clinicians could include patients in the study only if “coagulation factor deficiency was either known to exist (eg, as indicated by [elevated extrinsic pathway thromboelastometry] EXTEM clotting time or INR) or suspected based on the clinical situation” (see eTable 2 in our article’s Supplement 3). To minimize inclusion of patients who did not have coagulation factor deficiency and therefore would not have benefited from either therapy, an additional point-of-care INR was required after protamine reversal and before administration of the study therapies. We used INR for confirmation because it is familiar to clinicians, relatively inexpensive, easy to perform, insensitive to residual heparin effect, and able to reliably identify low (<50%) coagulation factor levels.