Stark M J

Collins C T

Andersen C C

Crawford T M

Sullivan T R

Bednarz J

Morton R

Marks D C

Dieng M

Owen L S

Opie G

Travadi J

Tan K

Morris S

2023-07-24

INTRODUCTION: Many extremely preterm newborns develop anaemia requiring a transfusion, with most receiving three to five transfusions during their admission. While transfusions save lives, the potential for transfusion-related adverse outcomes is an area of growing concern. Transfusion is an independent predictor of death and is associated with increased morbidity, length of hospital stay, risk of infection and immune modulation. The underlying mechanisms include adverse pro-inflammatory and immunosuppressive responses. Evidence supports an association between transfusion of washed red cells and fewer post-transfusion complications potentially through removal of chemokines, lipids, microaggregates and other biological response modifiers. However, the clinical and cost-effectiveness of washed cells have not been determined. METHODS AND ANALYSIS: This is a multicentre, randomised, double-blinded trial of washed versus unwashed red cells. Infants <28 weeks' gestation requiring a transfusion will be enrolled. Transfusion approaches will be standardised within each study centre and will occur as soon as possible with a recommended fixed transfusion volume of 15 mL/kg whenever the haemoglobin is equal to or falls below a predefined restrictive threshold, or when clinically indicated. The primary outcome is a composite of mortality and/or major morbidity to first discharge home, defined as one or more of the following: physiologically defined bronchopulmonary dysplasia; unilateral or bilateral retinopathy of prematurity grade >2, and; necrotising enterocolitis stage ≥2. To detect a 10% absolute reduction in the composite outcome from 69% with unwashed red blood cell (RBCs) to 59% with washed RBCs with 90% power, requires a sample size of 1124 infants (562 per group). Analyses will be performed on an intention-to-treat basis with a prespecified statistical analysis plan. A cost-effectiveness analysis will also be undertaken. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Women's and Children's Health Network Human Research Ethics Committee (HREC/12/WCHN/55). The study findings will be disseminated through peer-reviewed articles and conferences. TRIAL REGISTRATION NUMBER: ACTRN12613000237785 Australian New Zealand Clinical Trials Registry.

Department of Neonatal Medicine, The Women's and Children's Hospital Adelaide, Adelaide, South Australia, Australia Michael.stark@adelaide.edu.au.

Robinson Research Institute, The University of Adelaide, North Adelaide, South Australia, Australia.

SAHMRI Women and Kids Theme, South Australian Health and Medical Research Institute, North Adelaide, South Australia, Australia.

Department of Neonatal Medicine, The Women's and Children's Hospital Adelaide, Adelaide, South Australia, Australia.

School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.

National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.

Research and Development, Australian Red Cross Lifeblood New South Wales and Australian Capital Territory, Teams, New South Wales, Australia.

Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.

Critical Care and Neurosciences Division, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.

Department of Obstetrics & Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.

Neonatal Services, Mercy Hospital for Women, Heidelberg, Victoria, Australia.

Department of Paediatrics, Royal Darwin Hospital, Casuarina, Northern Territory, Australia.

Monah Newborn, Monash Children's Hospital, Clayton, Victoria, Australia.

Department of Paediatrics, Monash University, Clayton, Victoria, Australia.

College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.

Department of Neonatal Medicine, Flinders Medical Centre, Bedford Park, South Australia, Australia.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

BMJ Open. 2023 Jul 24;13(7):e070272. doi: 10.1136/bmjopen-2022-070272.

0000-0003-1835-8679

0000-0002-6930-5406

https://pubmed.ncbi.nlm.nih.gov/37487676/?otool=iaurydwlib

https://hdl.handle.net/10137/12510

13

Child

Female

Infant

Infant, Newborn

Humans

*Child Health

Australia

*Women's Health

Erythrocytes

Blood Transfusion

Randomized Controlled Trials as Topic

Multicenter Studies as Topic

Study protocol of the WashT Trial: transfusion with washed versus unwashed red blood cells to reduce morbidity and mortality in infants born less than 28 weeks' gestation - a multicentre, blinded, parallel group, randomised controlled trial.

Clinical Trial Protocol

Journal Article

Research Support, Non-U.S. Gov't

Publication