OBJECTIVE: 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 dose-escalation, 3 + 3 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 (3 + 3 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 The FFP transfusion rate was significantly reduced from 48.6% in a previous series involving 222 patients (unpublished historical data from our institution) to 0.6% (1 of 172 patients) in the present study (P < .001). The postoperative hospital stay in the present study was significantly shorter than that in our previous series (13 vs 16 days; P = .01). Total medical costs were significantly reduced from a median of $21 061 (range, 10 032-59 410) to $17 267 (11 823-35 785; P = .04). CONCLUSION: In liver resection, FFP transfusion is not necessary in patients with serum albumin levels higher than 2.4 g/dL on postoperative day 2.
RCT Entities:
OBJECTIVE: 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 dose-escalation, 3 + 3 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 (3 + 3 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 (P < .001). The postoperative hospital stay in the present study was significantly shorter than that in our previous series (13 vs 16 days; P = .01). Total medical costs were significantly reduced from a median of $21 061 (range, 10 032-59 410) to $17 267 (11 823-35 785; P = .04). CONCLUSION: In liver resection, FFP transfusion is not necessary in patients with serum albumin levels higher than 2.4 g/dL on postoperative day 2.