Yamazaki Shintaro, Takayama Tadatoshi, Kimura Yuki, Moriguchi Masamichi, Higaki Tokio, Nakayama Hisashi, Fujii Masashi, Makuuchi Masatoshi
Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Arch Surg. 2011 Nov;146(11):1293-9. doi: 10.1001/archsurg.2011.293.
To establish transfusion criteria for use of fresh frozen plasma (FFP) in liver resection.
Fresh frozen plasma has been transfused in liver resection without adequate supporting evidence, leading to unnecessary use.
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.
Hepatobiliary pancreatic surgery center of a university hospital.
Patients with hepatocellular carcinoma who had had Child-Pugh class A liver function and an intraoperative blood loss of less than 1000 mL.
Transfusion or no transfusion of FFP. Main Outcome Measure Reduction of transfusion rate in liver resection.
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 The FFP transfusion rate was significantly reduced from 48.6% in a previous series involving 222 patients (unpublished historical data from our institution) to 0.6% (1 of 172 patients) in the present study (P 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).
In liver resection, FFP transfusion is not necessary in patients with serum albumin levels higher than 2.4 g/dL on postoperative day 2.
建立肝切除术中新鲜冰冻血浆（FFP）的输注标准。
在肝切除术中输注新鲜冰冻血浆缺乏充分的支持证据，导致了不必要的使用。
采用前瞻性研究，使用1期剂量递增、3+3队列扩展设计，并针对FFP输注进行了修改。我们将血清白蛋白水平3.0 g/dL（第1步）指定为不输注的起始界限，并以0.2 g/dL的步长降低该水平。当3例患者的白蛋白水平等于上一步的目标值时，允许进入下一步。如果术后第2天的白蛋白值低于目标值，则在当天和术后第3天输注100 mL 25%的白蛋白。该研究持续进行，直到在未输血的情况下出现高级别术后并发症。如果3例患者中有1例发生Clavien-Dindo II级或更高等级的并发症，则在同一步骤中再增加3例患者（3+3队列）。
一所大学医院的肝胆胰外科中心。
肝功能为Child-Pugh A级且术中失血量少于1000 mL的肝细胞癌患者。
输注或不输注FFP。主要观察指标肝切除术中输血率的降低。
在连续纳入的213例肝癌患者中，172例患者（80.8%）符合纳入标准。步骤进展一直持续到第5步（白蛋白水平2.2 g/dL），未出现高级别并发症，但第2步（白蛋白水平2.8 g/dL）需要63例患者才能完成，因为有1例患者出现了II级并发症（大量腹水）。在第172例患者中，步骤进展在第5步中断，因为术后第2天的白蛋白值未降至第4步水平（2.4 g/dL）以下，该水平被定义为目标界限。总体手术发病率为27.9%；死亡率为0%。FFP输注率从之前涉及222例患者的系列研究中的48.6%（我们机构未发表的历史数据）显著降低至本研究中的0.6%（172例患者中的1例）（P<.001）。本研究中的术后住院时间明显短于我们之前的系列研究（13天对16天；P=.01）。总医疗费用从中位数21061美元（范围10032-59410美元）显著降低至17267美元（11823-35785美元；P=.04）。
在肝切除术中，术后第2天血清白蛋白水平高于2.4 g/dL的患者无需输注FFP。
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