Liver and Pancreas Unit, Department of Surgery, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Br J Surg. 2020 Jun;107(7):812-823. doi: 10.1002/bjs.11463. Epub 2020 Jan 22.
Major liver resection is associated with blood loss and transfusion. Observational data suggest that hypovolaemic phlebotomy can reduce these risks. This feasibility RCT compared hypovolaemic phlebotomy with the standard of care, to inform a future multicentre trial.
Patients undergoing major liver resections were enrolled between June 2016 and January 2018. Randomization was done during surgery and the surgeons were blinded to the group allocation. For hypovolaemic phlebotomy, 7-10 ml per kg whole blood was removed, without intravenous fluid replacement. Co-primary outcomes were feasibility and estimated blood loss (EBL).
A total of 62 patients were randomized to hypovolaemic phlebotomy (31) or standard care (31), at a rate of 3·1 patients per month, thus meeting the co-primary feasibility endpoint. The median EBL difference was -111 ml (P = 0·456). Among patients at high risk of transfusion, the median EBL difference was -448 ml (P = 0·069). Secondary feasibility endpoints were met: enrolment, blinding and target phlebotomy (mean(s.d.) 7·6(1·9) ml per kg). Blinded surgeons perceived that parenchymal resection was easier with hypovolaemic phlebotomy than standard care (16 of 31 versus 10 of 31 respectively), and guessed that hypovolaemic phlebotomy was being used with an accuracy of 65 per cent (20 of 31). There was no significant difference in overall complications (10 of 31 versus 15 of 31 patients), major complications or transfusion. Among those at high risk, transfusion was required in two of 15 versus three of nine patients (P = 0·326).
Endpoints were met successfully, but no difference in EBL was found in this feasibility study. A multicentre trial (PRICE-2) powered to identify a difference in perioperative blood transfusion is justified. Registration number: NCT02548910 ( http://www.clinicaltrials.gov).
大肝切除术会导致失血和输血。观察性数据表明，低血容量性采血可以降低这些风险。这项可行性随机对照试验将低血容量性采血与标准治疗进行比较，为未来的多中心试验提供信息。
2016 年 6 月至 2018 年 1 月期间，招募了接受大肝切除术的患者。手术期间进行随机分组，外科医生对分组分配不知情。对于低血容量性采血，每公斤全血采集 7-10ml，不进行静脉补液替代。主要的联合结局是可行性和估计失血量（EBL）。
共有 62 名患者被随机分为低血容量性采血组（31 名）或标准治疗组（31 名），每月进行 3.1 例患者的随机分组，因此满足了主要的可行性终点。中位 EBL 差值为-111ml（P=0.456）。在高输血风险的患者中，中位 EBL 差值为-448ml（P=0.069）。次要可行性终点也得到满足：招募、盲法和目标采血（平均（s.d.）7.6(1.9)ml/kg）。盲法外科医生认为低血容量性采血比标准治疗更容易进行实质切除术（分别为 31 名中的 16 名和 31 名中的 10 名），并猜测低血容量性采血的使用率为 65%（31 名中的 20 名）。总体并发症（31 名中的 10 名与 31 名中的 15 名）、主要并发症或输血无显著差异。在高风险患者中，15 名患者中有 2 名需要输血，9 名患者中有 3 名需要输血（P=0.326）。
本可行性研究中，各项终点均成功达到，但 EBL 无差异。一项旨在确定围手术期输血差异的多中心试验（PRICE-2）是合理的。注册号：NCT02548910（http://www.clinicaltrials.gov）。
