Red cell transfusion in outpatients with myelodysplastic syndromes: a feasibility and exploratory randomised trial

Oxford University, Oxford, United Kingdom. The John Radcliffe Hospital, Oxford, GBR. NHSBT, Oxford, United Kingdom. The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth, United Kingdom. Transfusion Research Unit, Monash University, Melbourne, Australia. Department of Haematology, Leeds Teaching Hospitals, Leeds, United Kingdom. Wellington Blood & Cancer Centre, Capital & Coast District Health Board, Wellington, New Zealand. Malaghan Institute of Medical Research, Wellington, New Zealand. NHS Blood and Transplant Clinical Trials Unit, Cambridge, United Kingdom. NHS Blood and Transplant Clinical Trials Unit, Bristol, United Kingdom. Department of Laboratory Medicine and Molecular Diagnostics, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada. Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.

British journal of haematology. 2020
PICO Summary

Population

Patients with myelodysplastic syndrome, (n=38).

Intervention

Restrictive transfusion threshold (80 g/l, to maintain haemoglobin 85-100 g/l), (n=20).

Comparison

Liberal transfusion threshold (105 g/l, to maintain haemoglobin 110-125 g/l), (n=18).

Outcome

The compliance proportion for the intention-to-treat population was 86% and 99% 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.
Abstract
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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine