Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery.
Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery.
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DOI：
10.1136/bmjopen-2017-016398
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发表时间：
2017-08-18
期刊：
影响因子：
2.9
通讯作者：
Kor DJ
中科院分区：
文献类型：
--
作者：
Warner MA;Welsby IJ;Norris PJ;Silliman CC;Armour S;Wittwer ED;Santrach PJ;Meade LA;Liedl LM;Nieuwenkamp CM;Douthit B;van Buskirk CM;Schulte PJ;Carter RE;Kor DJ
输血相关的呼吸系统并发症，输血相关的急性肺损伤（TRALI）和输血相关的循环超负荷（TACO），是输血相关的发病率和死亡率的主要原因。目前，没有有效的预防策略与红细胞（RBC）输注。虽然机制仍然不完全确定，红细胞储存溶液中的可溶性生物反应调节剂（BRM）可能发挥重要作用。同种异体RBC的护理点（POC）清洗可以去除这些BRM，从而减轻其对输血后呼吸系统并发症的影响。这是一项在接受心脏手术的成人患者中进行的标准同种异体红细胞输注与洗涤同种异体红细胞输注的多中心随机临床试验，旨在检验POC红细胞洗涤可行、安全和有效并将减少与输血相关呼吸并发症相关的受体免疫和生理反应的假设。还将评估相关临床结局。这项研究将在美国两家医院招募170名患者。Simon的两阶段设计将用于评估POC RBC洗涤的可行性。将使用Wilcoxon秩和检验（连续变量）和Pearson卡方检验（分类变量）评估主要安全性结局。将采用标准混合建模实践来检测输血后肺损伤生物标志物的变化。线性回归将评估随机分组与输血后生理指标之间的关系。将在独立数据和安全性监查委员会（DSMB）的指导下进行安全性监督。在入组第一名研究受试者之前，由DSMB以及各机构的机构审查委员会批准方案。本研究旨在提供关于同种异体红细胞POC洗涤的可行性及其对改善输血后呼吸系统并发症的潜在影响的重要信息。此外，它将告知进行更明确的II/III期临床试验的可行性和科学价值。ClinicalTrials.gov注册号为NCT 02094118（预结果）。
The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon’s two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. ClinicalTrials.gov registration number is NCT02094118 (Pre-results).
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影响因子：
2.9
作者：
Blumberg N;Heal JM;Gettings KF;Phipps RP;Masel D;Refaai MA;Kirkley SA;Fialkow LB
通讯作者：
Fialkow LB
影响因子：
5.8
作者：
Agouridakis P;Kyriakou D;Alexandrakis MG;Prekates A;Perisinakis K;Karkavitsas N;Bouros D
通讯作者：
Bouros D
影响因子：
5.7
作者：
Basran, Sukhjeewan;Frumento, Robert J.;Bennett-Guerrero, Elliott
通讯作者：
Bennett-Guerrero, Elliott
DOI：
10.1097/ta.0b013e3181c40728
发表时间：
2010-05
期刊：
The Journal of trauma
影响因子：
--
作者：
Fremont RD;Koyama T;Calfee CS;Wu W;Dossett LA;Bossert FR;Mitchell D;Wickersham N;Bernard GR;Matthay MA;May AK;Ware LB
通讯作者：
Ware LB
影响因子：
37.8
作者：
Donadee C;Raat NJ;Kanias T;Tejero J;Lee JS;Kelley EE;Zhao X;Liu C;Reynolds H;Azarov I;Frizzell S;Meyer EM;Donnenberg AD;Qu L;Triulzi D;Kim-Shapiro DB;Gladwin MT
通讯作者：
Gladwin MT