Red cell transfusion and QoL in myelodysplastic syndromes

ISRCTN	ISRCTN26088319
DOI	https://doi.org/10.1186/ISRCTN26088319
Secondary identifying numbers	17595

Submission date: 13/11/2014
Registration date: 13/11/2014
Last edited: 26/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-blood-transfusions-and-quality-of-life-in-people-with-myelodysplastic-syndrome

Contact information

Mrs Heather Smethurst
Scientific

NHSBT - Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom

Phone	01223 588110 (48110)
Email	heather.smethurst@nhsbt.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Red blood cell transfusion thresholds and Quality of Life in myelodysplastic syndromes: a pilot, feasibility study
Study acronym	REDDS
Study objectives	This pilot trial aims to find out if giving red blood cell transfusions to reach a higher haemoglobin concentration is possible, safe and would improve quality of life in patients with myelodysplastic syndromes (MDS). The results may help design a large multi-centre randomised, controlled trial to be conducted in the future, or may show that it is not possible to carry out such a trial.
Ethics approval(s)	NRES Committee South Central - Oxford A, 11/09/2014, ref. 14/SC/1150
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Haematological Oncology; Disease: Myelodysplastic syndromes
Intervention	Transfusion Strategy, Eligible, informed and consented patients will be randomised to one of two red cell transfusion strategies: 1. Restrictive transfusion strategy to maintain haemoglobin concentration level between 85 and 100g/L; where 2 units of packed red cell unit transfusions are transfused when the haemoglobin concentration level is < 80g/L and 1 unit of packed red cell unit transfusions when haemoglobin concentration level is 80-85g/L. 2. Liberal transfusion strategy to maintain haemoglobin concentration; Study Entry : Single Randomisation only
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	The primary outcomes of this feasibility study, from day 0 to day 84, will be: 1. The percentage compliance of pre-transfusion haemoglobin concentrations being within or above the target range of the red cell transfusion threshold assigned 2. Achievement of at least a 20 g/L difference between the mean pre-transfusion haemoglobins in the liberal and restrictive strategy groups
Secondary outcome measures	1. Number of patients ineligible due to screening failure or workload of department 2. Enrolment rates defined as number of patients enrolled per month, number of replaced patients and patient tolerability of study schedule 3. Percentage compliance with completing the QoL questionnaires at scheduled study visits 4. Ability of patients to remain blinded to the treatment arm 5. Proportion of transfusions and proportion of patients with all transfusions given correctly, according to the algorithm 6. Percentage of pre-transfusion haemoglobin concentrations falling below, within and above the target range of the red cell transfusion threshold assigned 7. The magnitude of change in physical functioning, fatigue, dyspnoea and global health scores on the EORTC QLQ-C30 and calculated health utility on the EQ-5D comparing the two RBC transfusion thresholds, with clinically significant differences of 10 points for the QLQ-C30 and 0.08 points for the EQ-5D 8. Numbers of adverse events such as cardiac events and thromboembolic events, and transfusion reactions (as defined and adapted from SHOT definitions and as applied in other NHSBT CTU trials), per arm 9. The overall utilisation of blood during study period per group, to evaluate the amount of extra red cell units transfused/week/patient associated with the liberal strategy
Overall study start date	10/11/2014
Completion date	30/10/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 38; UK Sample Size: 38; Description: 19 Patients in each arm (restrictive vs liberal transfusion strategy)
Total final enrolment	38
Key inclusion criteria	1. All patients with MDS =18 years of age and with < 20% blasts on bone marrow aspirate (WHO classification), including non-proliferative CMML and other MDS/MPN overlap diseases. These patients will include both those recently diagnosed and with an established diagnosis 2. Transfusion dependent: at least 1 red cell transfusion episode per month in the last 8 weeks 3. Life expectancy >6 months
Key exclusion criteria	1 .Unable, in the opinion of the attending clinician, to tolerate restrictive or liberal red cell transfusion thresholds (e.g. clinically significant cardio-respiratory compromise) 2. Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG =3) 3. Patients being actively treated with erythropiesis stimulating agents (ESAs) or disease modifying agents for their MDS (such as lenalidomide, azacitidine, hydroxycarbamide, experimental agents), as these may exert their own effects on the patients' quality of life and may render patients transfusion independent 4. Patients with myelofibrosis 5. Patients in whom the attending clinician considers that active bleeding or ongoing haemolysis contribute significantly to the cause of anaemia 6. Patients presenting with splenomegaly >5cm below the costal margin
Date of first enrolment	19/02/2015
Date of final enrolment	31/03/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

National Blood Service Oxford Centre

Oxford
OX3 9DU
United Kingdom

Sponsor information

NHS Blood and Transplant (NHSBT)
Hospital/treatment centre

National R&D Office
500 North Bristol Park
Northway
Bristol
BS34 7QH
England
United Kingdom

Website	http://www.nhsbt.nhs.uk/
"ROR"	https://ror.org/0227qpa16

Funders

Funder type

Government

NHS Blood and Transplant (NHSBT) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2020	26/01/2021	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

26/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/12/2018: The overall trial end date was changed from 31/12/2017 to 30/10/2018.
13/10/2016: Changed study contact details. Changed overall end date from 30/12/2016 to 31/12/2017. Changed recruitment end date from 31/07/2016 to 31/03/2017