Please use this identifier to cite or link to this item: http://hdl.handle.net/2381/37709
Title: Trial protocol for a randomised controlled trial of red cell washing for the attenuation of transfusion-associated organ injury in cardiac surgery: the REDWASH trial
Authors: Murphy, G. J.
Verheyden, V.
Wozniak, Marcin
Sullo, N.
Dott, W.
Bhudia, S.
Bittar, N.
Morris, T.
Ring, A.
Tebbatt, A.
Kumar, T.
First Published: 7-Mar-2016
Publisher: BMJ Publishing Group
Citation: Open Heart, 2016, 3 (1):e000344
Abstract: INTRODUCTION: It has been suggested that removal of proinflammatory substances that accumulate in stored donor red cells by mechanical cell washing may attenuate inflammation and organ injury in transfused cardiac surgery patients. This trial will test the hypotheses that the severity of the postoperative inflammatory response will be less and postoperative recovery faster if patients undergoing cardiac surgery receive washed red cells compared with standard care (unwashed red cells). METHODS AND ANALYSIS: Adult (≥16 years) cardiac surgery patients identified at being at increased risk for receiving large volume red cell transfusions at 1 of 3 UK cardiac centres will be randomly allocated in a 1:1 ratio to either red cell washing or standard care. The primary outcome is serum interleukin-8 measured at 5 postsurgery time points up to 96 h. Secondary outcomes will include measures of inflammation, organ injury and volumes of blood transfused and cost-effectiveness. Allocation concealment, internet-based randomisation stratified by operation type and recruiting centre, and blinding of outcome assessors will reduce the risk of bias. The trial will test the superiority of red cell washing versus standard care. A sample size of 170 patients was chosen in order to detect a small-to-moderate target difference, with 80% power and 5% significance (2-tailed). ETHICS AND DISSEMINATION: The trial protocol was approved by a UK ethics committee (reference 12/EM/0475). The trial findings will be disseminated in scientific journals and meetings. TRIAL REGISTRATION NUMBER: ISRCTN 27076315.
DOI Link: 10.1136/openhrt-2015-000344
eISSN: 2053-3624
Links: http://openheart.bmj.com/content/3/1/e000344
http://hdl.handle.net/2381/37709
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: Copyright © the authors, 2016. This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences



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