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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.

Publication ,  Journal Article
Warner, MA; Welsby, IJ; Norris, PJ; Silliman, CC; Armour, S; Wittwer, ED; Santrach, PJ; Meade, LA; Liedl, LM; Nieuwenkamp, CM; Douthit, B ...
Published in: BMJ Open
August 18, 2017

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).

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Published In

BMJ Open

DOI

EISSN

2044-6055

Publication Date

August 18, 2017

Volume

7

Issue

8

Start / End Page

e016398

Location

England

Related Subject Headings

  • Respiratory Insufficiency
  • Research Design
  • Pulmonary Edema
  • Point-of-Care Systems
  • Perioperative Care
  • Male
  • Lung
  • Immunologic Factors
  • Humans
  • Female
 

Citation

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Warner, M. A., Welsby, I. J., Norris, P. J., Silliman, C. C., Armour, S., Wittwer, E. D., … Kor, D. J. (2017). 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. BMJ Open, 7(8), e016398. https://doi.org/10.1136/bmjopen-2017-016398
Warner, Matthew A., Ian J. Welsby, Phillip J. Norris, Christopher C. Silliman, Sarah Armour, Erica D. Wittwer, Paula J. Santrach, et al. “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.BMJ Open 7, no. 8 (August 18, 2017): e016398. https://doi.org/10.1136/bmjopen-2017-016398.
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. 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. BMJ Open. 2017 Aug 18;7(8):e016398.

Published In

BMJ Open

DOI

EISSN

2044-6055

Publication Date

August 18, 2017

Volume

7

Issue

8

Start / End Page

e016398

Location

England

Related Subject Headings

  • Respiratory Insufficiency
  • Research Design
  • Pulmonary Edema
  • Point-of-Care Systems
  • Perioperative Care
  • Male
  • Lung
  • Immunologic Factors
  • Humans
  • Female