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Title: | Rethinking the transfusion pathway in myelodysplastic syndromes: Study protocol for a novel randomized feasibility n-of-1 trial of weekly-interval red cell transfusion in myelodysplastic syndromes. | Austin Authors: | Mo, Allison ;Wood, Erica;Shortt, Jake;Charlton, Andrew;Evers, Dorothea;Hoeks, Marlijn;Pritchard, Elizabeth;Daly, James;Hodgson, Carol;Opat, Stephen;Bowen, David;Reynolds, John;Thi Phung Thao, Le;Stanworth, Simon J;McQuilten, Zoe | Affiliation: | Transfusion Research Unit, School of Public Health & Preventive Medicine, Monash University, Australia.;Department of Haematology, Monash Health, Clayton, Australia.;Austin Pathology & Department of Haematology, Austin Health, Heidelberg, Australia. Transfusion Research Unit, School of Public Health & Preventive Medicine, Monash University, Australia.;Department of Haematology, Monash Health, Clayton, Australia. Department of Haematology, Monash Health, Clayton, Australia.;Department of Medicine, School of Clinical Sciences, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia. Department of Haematology, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.;Transfusion Medicine, NHS Blood and Transplant, Oxford, UK. Pathology Department of Haematology, Radboudumc, Nijmegen, The Netherlands. School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. Australian Red Cross Lifeblood, Melbourne, Australia. The Australian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne, Australia.;The Alfred, Melbourne, Australia.;The George Institute for Global Health, Sydney, Australia.;Department of Critical Care, The University of Melbourne, Melbourne, Australia. Department of Haematology, Monash Health, Clayton, Australia. Department of Health Sciences, University of York, York, UK. Department of Clinical Haematology, The Alfred, Melbourne, Australia.;Australian Centre for Blood Diseases, Central Clinical School, Monash University, Melbourne, Australia. Laboratory Haematology Transfusion Medicine, NHS Blood and Transplant, Oxford, UK.;Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.;Radcliffe Department of Medicine, University of Oxford, Oxford, UK. Transfusion Research Unit, School of Public Health & Preventive Medicine, Monash University, Australia.;Department of Haematology, Monash Health, Clayton, Australia. |
Issue Date: | 12-Jan-2024 | Date: | 2024 | Publication information: | Transfusion 2024-01-12 | Abstract: | Anemia in myelodysplastic syndromes (MDS) is associated with poorer health-related quality of life (HRQoL) and physical function, and is frequently treated with transfusions. The current common practice of transfusing multiple red blood cells (RBC) units every 2-4 weeks may result in peaks/troughs in hemoglobin (Hb) level, yet maintaining a stable Hb may better improve HRQoL. We describe a study protocol aiming to investigate the feasibility of weekly low-dose RBC transfusion in MDS patients, including assessing HRQoL and physical function outcomes. In this n-of-1 pilot study, patients receive two treatment arms, with randomly allocated treatment sequence: arm A (patient's usual transfusion schedule) and arm B (weekly transfusion, individualized per patient). To facilitate timely delivery of weekly transfusion, extended-matched RBCs are provided, with transfusion based upon the previous week's Hb/pre-transfusion testing results to eliminate delays of awaiting contemporaneous cross-matching. Primary outcome is the feasibility of delivering weekly transfusion. Secondary outcomes include HRQoL, functional activity measurements, RBC usage, and alloimmunization rates. A qualitative substudy explores patient and staff experiences. The trial is open in Australia, Netherlands, and UK. The first patient was recruited in 2020. Inter-country differences in providing RBCs are observed, including patient genotyping versus serological phenotyping to select compatible units. This pilot trial evaluates a novel personalized transfusion approach of weekly matched RBC transfusion and challenges the dogma of current routine pre-transfusion matching practice. Findings on study feasibility, HRQoL, and physical functional outcomes and the qualitative substudy will inform the design of a larger definitive trial powered for clinical outcomes. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/34868 | DOI: | 10.1111/trf.17706 | ORCID: | 0000-0002-1923-3133 0000-0001-9661-6835 0000-0001-9698-7185 |
Journal: | Transfusion | PubMed URL: | 38214417 | ISSN: | 1537-2995 | Type: | Journal Article | Subjects: | RBC transfusion transfusion practices (adult) transfusion practices (oncology-hematology) |
Appears in Collections: | Journal articles |
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