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Randomized Controlled Trial
. 2017 Aug 18;7(8):e016398.
doi: 10.1136/bmjopen-2017-016398.

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

Matthew A Warner  1 , Ian J Welsby  2 , Phillip J Norris  3 , Christopher C Silliman  4 , Sarah Armour  5 , Erica D Wittwer  5 , Paula J Santrach  6 , Laurie A Meade  5 , Lavonne M Liedl  5   7 , Chelsea M Nieuwenkamp  6 , Brian Douthit  2 , Camille M van Buskirk  8 , Phillip J Schulte  7 , Rickey E Carter  7 , Daryl J Kor  5
Affiliations
Randomized Controlled Trial

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

Matthew A Warner et al. BMJ Open. .

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Registration: ClinicalTrials.gov registration number is NCT02094118 (Pre-results).

Keywords: Adult Anaesthesia; Anaemia.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Schematic of the planned study procedures. ALI, acute lung injury; CATS, Continuous Autotransfusion System; CCL5, chemokine ligand 5; CFH, cell free haemoglobin; CHF, congestive heart failure; FiO2, fraction of inspired oxygen; Hb, haemoglobin; MAP, mean arterial pressure; PAI-1, plasminogen activator inhibitor 1; PaO2, arterial partial pressure of oxygen; PCWP, pulmonary capillary wedge pressure; PEEP, positive end expiratory pressure; PO, postoperative; POD, postoperative day; RAGE, receptor of advanced glycation end-products; RBC, red blood cell; RBC-MP, red blood cell microparticle; Rxs, reactions; sCD40L, soluble CD40 ligand; SOFA, sequential organ failure assessment; SpO2, oxygen saturation by pulse oximetry; SVR, systemic vascular resistance; TACO, transfusion-associated circulatory overload; TRALI, transfusion-related acute lung injury; Trx, transfusion.
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