Condition category
Cancer
Date applied
13/11/2014
Date assigned
13/11/2014
Last edited
13/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mrs Heather Smethurst

ORCID ID

Contact details

NHSBT - Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom
01223 588110 (48110)
heather.smethurst@nhsbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17595

Study information

Scientific title

Red blood cell transfusion thresholds and Quality of Life in myelodysplastic syndromes: a pilot, feasibility study

Acronym

REDDS

Study hypothesis

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

NRES Committee South Central - Oxford A, 11/09/2014, ref. 14/SC/1150

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

10/11/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 38; UK Sample Size: 38; Description: 19 Patients in each arm (restrictive vs liberal transfusion strategy)

Participant 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

Recruitment start date

19/02/2015

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Blood Service –Oxford Centre
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

NHS Blood and Transplant (NHSBT)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.nhsbt.nhs.uk/

Funders

Funder type

Government

Funder name

NHS Blood and Transplant (NHSBT) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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