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Background: In patients with cirrhosis, the synthesis of coagulation factors can fall short, reflected by a prolonged prothrombin time. Although anticoagulants factors are decreased as well, blood loss during orthotopic liver transplantation can still be excessive. Blood loss during orthotopic liver transplantation is currently managed by transfusion of red blood cell concentrates, platelet concentrates, fresh frozen plasma, and fibrinogen concentrate. Transfusion of these products may paradoxically result in an increased bleeding tendency due to aggravated portal hypertension. The hemostatic effect of these products may therefore be overshadowed by bleeding complications due to volume overload.In contrast to these transfusion products, prothrombin complex concentrate is a low-volume highly purified concentrate, containing the four vitamin K dependent coagulation factors. Previous studies have suggested that administration of prothrombin complex concentrate is an effective method to normalize a prolonged prothrombin time in patients with liver cirrhosis. We aim to investigate whether the pre-operative administration of prothrombin complex concentrate in patients undergoing liver transplantation for end-stage liver cirrhosis, is a safe and effective method to reduce perioperative blood loss and transfusion requirements., Methods/design: This is a double blind, multicenter, placebo-controlled randomized trial.Cirrhotic patients with a prolonged INR (≥1.5) undergoing liver transplantation will be randomized between placebo or prothrombin complex concentrate administration prior to surgery. Demographic, surgical and transfusion data will be recorded. The primary outcome of this study is RBC transfusion requirements., Discussion: Patients with advanced cirrhosis have reduced plasma levels of both pro- and anticoagulant coagulation proteins. Prothrombin complex concentrate is a low-volume plasma product that contains both procoagulant and anticoagulant proteins and transfusion will not affect the volume status prior to the surgical procedure. We hypothesize that administration of prothrombin complex concentrate will result in a reduction of perioperative blood loss and transfusion requirements. Theoretically, the administration of prothrombin complex concentrate may be associated with a higher risk of thromboembolic complications. Therefore, thromboembolic complications are an important secondary endpoint and the occurrence of this type of complication will be closely monitored during the study., Trial Registration: The trial is registered at http://www.trialregister.nl with number NTR3174. This registry is accepted by the ICMJE.

Background: Bedside thromboelastography is increasingly used, but an assessment of the clinical interchangeability of the 2 major systems, TEG (Hemoscope) and RoTEM (Pentapharm), has not been performed., Methods: We measured blood samples from 46 cardiac surgical patients after induction of anesthesia with kaolin TEG(R) (kaoTEG), native TEG(R) (natTEG), intrinsic RoTEM (inTEM), and extrinsic RoTEM (exTEM). Each measurement consisted of reaction time (R), coagulation time (K), maximum amplitude (MA), and angle (alpha). Bland-Altman plots and mixed-model analysis were used. To assess repeatability, we made 7 replicated measurements in rapid succession in 2 volunteers., Results: One hundred sixty-six measurements were available for analysis. The R time of the kaoTEG (345 + or - 102 seconds, mean + or - sd) was longer than that of the inTEM (179 + or - 74 seconds, P < 0.001) and the exTEM (55 + or - 28 seconds, P < 0.001). The K time of the kaoTEG (78 + or - 18s) was not different from that of the inTEM (75 + or - 52 seconds, P = 0.60) but was longer than the K time of the exTEM (61 + or - 24 seconds, P < 0.003). The MA of the kaoTEG (71 + or - 6.5 mm) was larger than the MA of the inTEM (67 + or - 5.2 mm, P < 0.02) and almost similar to that of the exTEM (69 + or - 6.3 mm). The alpha of the kaoTEG (72 degrees + or - 4.1 degrees ) was not significantly different from that of both the inTEM (76 degrees + or - 7 degrees ) and the exTEM (79 degrees + or - 4.5 degrees ). The variability for MA and alpha was <10%. The repeatability of the R and K times was poor in both devices, whereas the repeatability of the MA and alpha was sufficient for clinical purposes., Conclusions: The TEG and RoTEM measurements demonstrated a close correlation for the MA, but the alpha did not for the R and K variables. The kaoTEG had the best agreement with the exTEM measurement. Therefore TEG and RoTEM measurements are not completely interchangeable, and the clinical interpretation of thromboelastograhic data should be used with caution.