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Red cell transfusion in outpatients with myelodysplastic syndromes: a feasibility and exploratory randomised trial
Author(s) -
Stanworth Simon J.,
Killick Sally,
McQuilten Zoe K.,
Karakantza Marina,
Weinkove Robert,
Smethurst Heather,
Pankhurst Laura A.,
Hodge Renate L.,
Hopkins Valerie,
Thomas Helen L.,
Deary Alison J.,
Callum Jeannie,
Lin Yulia,
Wood Erica M.,
Buckstein Rena,
Bowen David
Publication year - 2020
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.16347
Subject(s) - medicine , confidence interval , population , myelodysplastic syndromes , randomized controlled trial , blood transfusion , quality of life (healthcare) , exploratory analysis , pediatrics , bone marrow , nursing , environmental health , data science , computer science
Summary Optimal red cell transfusion support in myelodysplastic syndromes (MDS) has not been tested and established. The aim of this study was to demonstrate feasibility of recruitment and follow‐up in an outpatient setting with an exploratory assessment of quality of life (QoL) outcomes (EORTC QLQ‐C30 and EQ‐5D‐5L). We randomised MDS patients to standardised transfusion algorithms comparing current restrictive transfusion thresholds (80 g/l, to maintain haemoglobin 85–100 g/l) with liberal thresholds (105 g/l, maintaining 110–125 g/l). The primary outcomes were measures of compliance to transfusion thresholds. Altogether 38 patients were randomised ( n = 20 restrictive; n = 18 liberal) from 12 participating sites in UK, Australia and New Zealand. The compliance proportion for the intention‐to‐treat population was 86% (95% confidence interval 75–94%) and 99% (95–100%) for restrictive and liberal arms respectively. Mean pre‐transfusion haemoglobin concentrations for restrictive and liberal arms were 80 g/l (SD6) and 97 g/l (SD7). The total number of red cell units transfused on study was 82 in the restrictive and 192 in the liberal arm. In an exploratory analysis, the five main QoL domains were improved for participants in the liberal compared to restrictive arm. Our findings support the feasibility and need for a definitive trial to evaluate the effect of different red cell transfusion thresholds on patient‐centred outcomes.