REd cell transfusion in Acute myeloid Leukaemia (REAL), v 1.0
Research type
Research Study
Full title
REd cell transfusion in Acute myeloid Leukaemia
IRAS ID
210454
Contact name
Simon Stanworth
Contact email
Sponsor organisation
NHS Blood & Transplant
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Research Summary
This is a small pilot, feasibility study for a possible multi-centre randomised, controlled trial comparing quality of life (QoL) at two haemoglobin (Hb) levels in patients with Acute Myeloid Leukaemia (AML).
During chemotherapy treatment, patients may develop anaemia (get low levels of red cells in the circulation). Currently red blood cell (RBC) transfusions are usually given when a patient’s haemoglobin falls to around 80 g/L but patients may still feel short of breath and tired. However, some recent research suggests that giving red blood cell transfusions to keep the patient’s haemoglobin level higher may result in improved functioning and fewer symptoms. Patients could need more transfusions to achieve this higher level which itself may lead to its own side effects. Clinical studies are required to help us understand the best strategy for use of red blood cell transfusions in AML.
Patients will participate in this study for the first two cycles of their chemotherapy only. Participants will be randomly allocated to one threshold of haemoglobin for their first course of chemotherapy and the other for their second course. The 2 thresholds are; restrictive threshold ( ≤70 g/L) and liberal threshold ( ≤90 g/L).
Participants will be asked to fill in short questionnaires about their quality of life at certain intervals during their treatment. Each patient will be in the trial until end of their chemotherapy cycle 2 (approximately 3 months).
Summary of Results
Patients diagnosed with acute myeloid leukemia (AML) and going through chemotherapy treatment are in need of red cell (RBC) transfusion to prevent severe anaemia and improve quality of life (wellbeing). There is no conclusive clinical research to provide guidance on the best transfusion level in these patients.
A total of 43 participants were recruited into the study from eight hospitals in the United Kingdom.
Participants, with acute myeloid leukaemia and meeting the inclusion criteria, were randomised into two groups, for during their first two cycles of intensive chemotherapy:
Group A -During their first cycle, they were given a blood transfusion if their haemoglobin was 70g/l or lower.
During their second cycle, they were given a blood transfusion if their haemoglobin was 90g/l or lower.
Group B
During their first cycle, they were given a blood transfusion if their haemoglobin was 90g/l or lower.During their second cycle, they were given a blood transfusion if their haemoglobin was 70g/l or lower.
21 participants were in group A and 22 participants were in group B.
The research team looked to see how frequently transfusions were received at these levels: for the lower cycle this occurred 91.6% of the time and for the higher group 70.7% of the time. As both of these values were above 70%, the target set at the beginning of the study was achieved.
A total of 152 red cell transfusions were given to participants when they were in the lower threshold cycle and 295 to participants in the higher threshold cycle.
Participants were also asked to complete 2 simple quality of life questionnaires at intervals during their treatment.
Participants in the higher threshold cycle reported a better quality of life in five of the areas of questions but the y were better at completing the questionnaires at the start of the study than later on.
The results of the study suggest it will be possible to run a larger trial and that there is a need to study the effect of different red cell transfusion thresholds on patient-centred outcomes.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0406
Date of REC Opinion
24 Sep 2016
REC opinion
Further Information Favourable Opinion