title: Transfusion criteria for fresh frozen plasma in liver resection: a 3 + 3 cohort expansion study.
abstract: 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.
  
  
  METHODS
  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.
  
  
  METHODS
  Hepatobiliary pancreatic surgery center of a university hospital.
  
  
  METHODS
  Patients with hepatocellular carcinoma who had had Child-Pugh class A liver function and an intraoperative blood loss of less than 1000 mL.
  
  
  METHODS
  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 The FFP transfusion rate was significantly reduced from 48.6% in a previous series involving 222 patients (unpublished historical data from our institution) to 0.6% (1 of 172 patients) in the present study (P 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).
  
  
  CONCLUSIONS
  In liver resection, FFP transfusion is not necessary in patients with serum albumin levels higher than 2.4 g/dL on postoperative day 2.
authors: Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
authors: Shintaro
authors: S
authors: Yamazaki
authors: Tadatoshi
authors: T
authors: Takayama
authors: Yuki
authors: Y
authors: Kimura
authors: Masamichi
authors: M
authors: Moriguchi
authors: Tokio
authors: T
authors: Higaki
authors: Hisashi
authors: H
authors: Nakayama
authors: Masashi
authors: M
authors: Fujii
authors: Masatoshi
authors: M
authors: Makuuchi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016913:Blood Component Transfusion / Q000592:standards*; D016063:Blood Loss, Surgical / Q000517:prevention & control* / Q000706:statistics & numerical data; D006528:Carcinoma, Hepatocellular / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006498:Hepatectomy; D006801:Humans; D015994:Incidence; D007430:Intraoperative Care / Q000379:methods* / Q000592:standards; D007564:Japan / Q000453:epidemiology; D008113:Liver Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010949:Plasma; D019106:Postoperative Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult