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To establish transfusion criteria for use of fresh frozen plasma (FFP) in liver resection.Background: Fresh frozen plasma has been transfused in liver resection without adequate supporting evidence, leading to unnecessary use.Design: Prospective study using a phase 1 doseescalation, 3ϩ3 cohort expansion design, modified for FFP transfusion. We designated a serum albumin level of 3.0 g/dL (step 1) as the starting limit for no transfusion and reduced the level in 0.2-g/dL steps. Advancement to the next step was permitted when the albumin level equaled the target value for the previous step in 3 patients. If the albumin value on postoperative day 2 fell below the target value, 100 mL of albumin, 25%, was transfused on that day and on postoperative day 3. The study continued until high-grade postoperative complications occurred without transfusion. If 1 of 3 patients developed Clavien-Dindo grade II or higher complications, 3 more patients (3ϩ3 cohort) were added to the same step.Setting: Hepatobiliary pancreatic surgery center of a university hospital.Patients: Patients with hepatocellular carcinoma who had had Child-Pugh class A liver function and an intraoperative blood loss of less than 1000 mL. Intervention: Transfusion or no transfusion of FFP.Main Outcome Measure: Reduction of transfusion rate in liver resection.Results: Of the 213 consecutive patients with liver cancer enrolled, 172 patients (80.8%) fulfilled the inclusion criteria.Step progression proceeded until step 5 (albumin level, 2.2 g/dL) without high-grade complications, but step 2 (albumin level, 2.8 g/dL) required 63 patients to complete because 1 patient developed grade II complications (massive ascites).Step progression was broken off at step 5 in the 172nd patient because the postoperative day 2 albumin value did not fall below the step 4 level (2.4 g/dL), defined as the goal limit. The overall operative morbidity rate was 27.9%; the mortality rate was 0%. The FFP transfusion rate was significantly reduced from 48.6% in a previous series involving 222 patients (unpublished historical data from our institution) to 0.6% (1 of 172 patients) in the present study (PϽ .001). The postoperative hospital stay in the present study was significantly shorter than that in our previous series (13 vs 16 days; P=.

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