University of Miami
The overall objective of this study is to determine whether ROTEM (rotational thromboelastometry) guided dosing of four-factor prothrombin complex concentrate (4F-PCC) results in superior perioperative bleeding control compared to clinician-directed. PCC administration in adult patients undergoing high-risk cardiac surgery with cardiopulmonary bypass (CPB) who develop post-CPB coagulopathic bleeding.
Inclusion Criteria: * Age \>= 18 years * Undergoing high-risk cardiac surgery with cardiopulmonary bypass, defined as any one or more of: (a) reoperation/redo cardiac surgery; (b) combined valve surgery and Coronary Artery Bypass Grafting (CABG); (c) aortic root or ascending aortic surgery; (d) surgery requiring hypothermic circulatory arrest; (e) active preoperative anticoagulation \[Vitamin K Antagonist (VKA), Direct Oral Anti-Coagulant (DOAC), or therapeutic heparin/ Low Molecular Weight Heparin (LMWH)\] within 5 days of surgery * Clinically significant post-cardio pulmonary bypass (CPB) c…
4-factor prothrombin complex concentrate (4F-PCC; Kcentra, CSL Behring) administered by intravenous infusion according to package insert instructions. Dosing is determined according to study arm assignment.
ROTEM (Rotational Thromboelastometry) analyzer (TEM International GmbH), an FDA-cleared point-of-care coagulation monitoring device used to guide PCC dosing decisions.
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