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Protocol
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
  1. G J Murphy1,
  2. V Verheyden1,
  3. M Wozniak1,
  4. N Sullo1,
  5. W Dott1,
  6. S Bhudia2,
  7. N Bittar3,
  8. T Morris4,
  9. A Ring4,
  10. A Tebbatt5 and
  11. T Kumar1
  1. 1Department of Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, University of Leicester, Clinical Sciences Wing, Glenfield Hospital, Leicester, UK
  2. 2University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
  3. 3Blackpool Victoria Hospital NHS Trust, Blackpool, UK
  4. 4Leicester Clinical Trials Unit, Leicester Diabetes Centre, Leicester General Hospital, Leicester, UK
  5. 5Department of Clinical Perfusion, University Hospital Leicester NHS Trust, Glenfield Hospital, Leicester, UK
  1. Correspondence to Professor GJ Murphy; gjm19{at}leicester.ac.uk

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.

  • CARDIAC SURGERY

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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