Red cell transfusion and QoL in myelodysplastic syndromes (REDDS)
Research type
Research Study
Full title
Red blood cell transfusion thresholds and Quality of Life in myelodysplastic syndromes: a pilot, feasibility study.
IRAS ID
158370
Contact name
Gillian Powter
Contact email
Sponsor organisation
NHS Blood and Transplant
Research summary
This is a pilot feasibility study for a possible multi-centre randomised controlled trial comparing quality of life (QoL) at two blood haemoglobin (Hb) levels in patients with MDS.
Myelodysplastic syndromes (MDS) are bone marrow disorders which impair the production of the correct quality and quantity of blood cells. Many patients develop anaemia (low levels of red cells in the circulation) which can persist for many years. Treatment of MDS is focused on relieving the symptoms of anaemia, thus patients frequently receive blood tranfsusions. These patients are considered dependent on red blood cell (RBC) transfusions. Although a large group of haematology patients has MDS, there is no high quality data on safe and effective Hb thresholds in transfusion dependent MDS patients.
Currently RBC transfusions are usually given when the patient's Hb falls to 80-85g/L. This is to prevent serious complications, such as heart disease, but patients may still feel short of breath and tired. However some recent research suggests that giving RBCs to keep the patient's Hb at a higher level (100g/L) may result in improved functioning and fewer symptoms. Patients could need more hospital visits to achieve this higher level and it is possible that increased transfusion of RBC will have its own side effects.
Clinical studies are required to help understand the best strategy for use of RBC transfusions in MDS. In this trial patients will be allocated to a restrictive Hb transfusion threshold (85-100g/L) or a liberal threshold (110-125g/L) policy with QoL as the primary endpoint. Before each transfusion patients will be asked to complete a short QoL questionnaire and another a week later. Each patient will be in the trial for 12 to 18 weeks. The pilot results will inform the design and practicalities of any larger study.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1150
Date of REC Opinion
12 Sep 2014
REC opinion
Further Information Favourable Opinion