Red cell transfusion in outpatients with myelodysplastic syndromes: a feasibility and exploratory randomised trial.
clinical transfusion medicine
clinical trials
quality of life
red cells
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
09
09
2019
accepted:
06
10
2019
pubmed:
22
1
2020
medline:
15
12
2020
entrez:
22
1
2020
Statut:
ppublish
Résumé
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.
Banques de données
ISRCTN
['ISRCTN26088319']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
279-290Subventions
Organisme : Wellington Division of the New Zealand Cancer Society
Pays : International
Organisme : Medical Research Council
ID : MC_UU_00016/11
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12009/11
Pays : United Kingdom
Organisme : NHSBT R&D
Pays : International
Organisme : UK's National Institute for Health Research (NIHR)
Pays : International
Organisme : Medical Research Council
ID : MC_U137961146
Pays : United Kingdom
Organisme : Medical Research Council
ID : G1000729
Pays : United Kingdom
Organisme : Australian and New Zealand Society of Blood Transfusion (ANZSBT)
Pays : International
Organisme : Medical Research Council
ID : MR/L008963/1
Pays : United Kingdom
Organisme : NHS Blood and Transplant Clinical Trials Unit
Pays : International
Investigateurs
Louise Wallis
(L)
Taslima Rabbi
(T)
Monica Serrano
(M)
Rachel Williams
(R)
Joe Chacko
(J)
Julia Darlow
(J)
Lucy Watson
(L)
Kelli Earley
(K)
Naomi Haas
(N)
Lois Woods
(L)
Carla Dimitriu
(C)
James Croft
(J)
Ana Carvalhosa
(A)
Christine Clarke
(C)
Tim Hickish
(T)
Christina Penny
(C)
Alex Sternberg
(A)
Tim Owen
(T)
Cerila Parajes
(C)
Chanelle Meyer
(C)
Jan Dodge
(J)
Sue Meakin
(S)
Donna Lake
(D)
Dominic Culligan
(D)
Helen Fletcher
(H)
Hazel Forbes
(H)
Nicola Johannesson
(N)
Gordon Taylor
(G)
Jill Tomlinson
(J)
Ann Shaw
(A)
Maria Ratcliffe
(M)
Mariella Lamacchia
(M)
Mark Vickers
(M)
Caroline Duncan
(C)
Paraskevi Untiveros
(P)
Adetomilola Olaiya
(A)
Jane Tighe
(J)
Gavin Preston
(G)
Mehmood Zaidi
(M)
Alastair Lawrie
(A)
Charlotte Robertson
(C)
Haifaa Saadi
(H)
Uzunma Onyeakazi
(U)
Rohini Radia
(R)
Thomas Father
(T)
Katherine Stainthorp
(K)
Steward Mc Connell
(S)
Terry Booth
(T)
Catherine Langton
(C)
Clare Howcroft
(C)
Ismail Saddiq
(I)
Emma das Gupta
(ED)
Jennifer Byrne
(J)
Jo Lindsey-Hill
(J)
Denise Badder
(D)
Melanie Jones
(M)
Raj Pol
(R)
Paresh Vyas
(P)
Adam Mead
(A)
Andrew Peniket
(A)
Rachel Bancroft
(R)
Sally Springett
(S)
Shobana Yoganayagam
(S)
Louisa Gray
(L)
Heather Friesen
(H)
Katrin Wardle
(K)
Vidhya Murthy
(V)
Guy Pratt
(G)
Bhuvan Kishore
(B)
Georgina Mayer
(G)
Emmanouil Nikolousis
(E)
Neil Smith
(N)
Richard Lovell
(R)
Charalampos Kartsios
(C)
Joanne Ewing
(J)
Matthew Lumley
(M)
Jahanzeb Khawaja
(J)
Majed Ali
(M)
David Sutton
(D)
Duncan Murray
(D)
Donald Milligan
(D)
Sundip Dhani
(S)
Mary O'Sullivan
(M)
James Whitehouse
(J)
Anne Schumacher
(A)
Rosemarie Enstone
(R)
Alison Hardy
(A)
Melanie Kelly
(M)
Jonathan Wallis
(J)
Lauren Boal
(L)
Mark Davies
(M)
Ruth Latter
(R)
Joanne Wincup
(J)
Steven Ellis
(S)
Sonia Poolan
(S)
Mark Birt
(M)
Emily Watts
(E)
Andrew Charlton
(A)
Hazel Forsyth
(H)
Louisa Waring
(L)
Julie Twohig
(J)
Helen Marr
(H)
Anne Lennard
(A)
Gail Jones
(G)
Tobias Menne
(T)
Nicola Redding
(N)
Susan Jones
(S)
Kate Robinson
(K)
Effie Grand
(E)
Jonathan Cullis
(J)
Freya Collins
(F)
Louise Gamble
(L)
Jenny Brown
(J)
Saffron Tudgay
(S)
Sarah Salisbury
(S)
Siju Mathew
(S)
Nicole Tipler
(N)
Tracey Parker
(T)
Emma Stobie
(E)
Michele Tribbeck
(M)
Sangam Hebballi
(S)
Christopher Millar
(C)
David Allotey
(D)
Jai Lala
(J)
Nicole McGee
(N)
Jo Chmeil
(J)
Lianne Hufton
(L)
Sarah Dawson
(S)
Rob Weincove
(R)
Duncan Smyth
(D)
Hubertus Buyck
(H)
Jina Hayden
(J)
Anup George
(A)
Israel Baluwala
(I)
Matthew Wheeler
(M)
Lisa Daysh
(L)
Owain Williams
(O)
Susan Millmow
(S)
Rebecca Miles
(R)
Sushi Geller
(S)
Maureen Blakemore
(M)
Ann Hargreaves
(A)
Gina Hayden
(G)
Allison Mo
(A)
Matt Van Dam
(M)
Micheleine Uhe
(M)
Tishya Indran
(T)
Jonathan Wong
(J)
Liz Coughlin
(L)
Alan MacWhannell
(A)
Claire Beardsmore
(C)
Lucy Lunn
(L)
Sharon Pearson
(S)
Simon Shaw
(S)
Jane Parker
(J)
Angela Bowen
(A)
Andrea Jones
(A)
Matthew Player
(M)
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 British Society for Haematology and John Wiley & Sons Ltd.
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