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

G J Murphy, V Verheyden, M Wozniak, N Sullo, W Dott, S Bhudia, N Bittar, T Morris, A Ring, A Tebbatt, T Kumar, G J Murphy, V Verheyden, M Wozniak, N Sullo, W Dott, S Bhudia, N Bittar, T Morris, A Ring, A Tebbatt, T Kumar

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.

Keywords: CARDIAC SURGERY.

Figures

Figure 1
Figure 1
Annexin V (AV) positive microvesicles (MV) in allogenic red cell stored in SAGM at 4°C for up to 42 days and after washing with a Fresenius Continuous AutoTransfusion System (CATS, Fresenius AG, Bad Homburg, Germany). SAGM, saline adenine glucose mannitol.
Figure 2
Figure 2
Individual patient data meta-analysis showing serial interleukin (IL)-8 levels measured up to 48 h postsurgery in transfused and non-transfused patients from historical data.
Figure 3
Figure 3
Patient flows showing randomisation, intervention period and follow-up period. Hct, haematocrit; RBC, red blood cell.

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