Contact information
Type
Public
Primary contact
Mrs Heather Smethurst
ORCID ID
Contact details
Clinical Trials Unit
NHS Blood & Transplant
Cambridge Blood Donor Centre
Long Road
Cambridge
CB2 0PT
United Kingdom
+44 7471 147896
heather.smethurst@nhsbt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31999
Study information
Scientific title
REd cell transfusion in Acute myeloid Leukaemia (REAL)
Acronym
REAL
Study hypothesis
The aim of this study is to investigate the feasibility of conducting a multi-centre randomised, controlled trial comparing quality of life (QoL) at two haemoglobin (Hb) levels in patients with Acute Myeloid Leukaemia (AML).
Ethics approval
RES Committee South Central -Oxford A, 24/09/2016, ref: 16/WM/0406
Study design
Randomised; Interventional; Design type: Treatment, Management of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Haematological Oncology; UKCRC code/ Disease: Cancer/ Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissu
Intervention
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). The study will run, for a each participant, for their first 2 courses of chemotherapy only (approximately 42 days per course). The participant would be randomised by an online randomisation system at www.sealedenvelope.com. Their randomisation result will be which arm of the trial they will be in for Cycle One of their chemotherapy treatment. The participant will cross over to the other arm for Cycle Two of their chemotherapy treatment.
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).
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Percentage of pre-transfusion haemoglobin concentrations being within target range of the assigned red cell transfusion strategy is measured using patient notes at pre every red cell transfusion
2. Achievement of at least a 15g/L difference between the mean pre-transfusion haemoglobins in the 2 randomisation groups is measured patient notes at pre every red cell transfusion
Secondary outcome measures
Adherence outcomes:
1. Transfusions given per protocol is assessed using patient notes and haemoglobin blood test results at the point of each transfusion
2. Red cell exposure is assessed using patient notes at the end of each cycle of chemotherapy
3. Adherence to outcome monitoring is assessed using review of trial case report forms data at time of forms arriving in CTU and at the end of the trial period
4. Recruitment rate is assessed using screening records at regular intervals
5. Characteristics of recruited participants are assessed using reviewing patient notes at the start of the trial
Clinical outcomes:
1. Bleeding rate is measured using number of severe bleeds reported at the end of each cycle of chemotherapy
2. Thrombosis rate is measured using number of thrombotic events reported at the end of each cycle of chemotherapy
3. Culture verified bacterial infections is measured using blood culture test results at the end of each cycle of chemotherapy
4. Platelet transfusion rate is measured using number of platelet transfusions recorded in patient notes at the end of each cycle of chemotherapy
5. Quality of Life (QoL) is measured using EQ-5D-5L and EORTC QLQ C30 questionnaires at 5 points during the study period (start of study, mid-cycle 1, between cycle 1 and cycle 2, mid cycle 2, end of study). Also only part b of the EQ-5D-5L will be daily assessed.
6. Transfusion reactions are measured using a transfusion reaction reporting form at each instance of a transfusion reaction.
7. Mortality rate is assessed using patient notes at 3 months after end of study
Compliance with data collection between sites is assessed using central monitoring of datasets received at point of receiving them and at point of adding the datasets to the database.
Primary outcome:
1. Percentage of pre-transfusion haemoglobin concentrations being within target range of the assigned red cell transfusion strategy is measured using patient notes and blood test results at each red cell transfusion
2. Achievement of at least a 15g/L difference between the mean pre-transfusion haemoglobins in the 2 randomisation groups is measured patient notes and blood test results at each red cell transfusion
Overall trial start date
01/04/2016
Overall trial end date
01/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults aged 18 years and over
2. Diagnosis of de novo acute myeloid leukaemia (AML) or relapsed AML
3. Undergoing treatment with intensive chemotherapy with an expectation of receiving a minimum of 2 cycles (excluding stem cell transplant)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 36; UK Sample Size: 36
Participant exclusion criteria
1. Patients for whom the attending haematologist feels allocation to either a restrictive or liberal policy of red cell transfusion is not justified (e.g. clinically significant cardiovascular disease)
2. Acute promyelocytic leukaemia (APML)
3. Patients who have been diagnosed with myelodysplasia prior to diagnosis of AML.
Recruitment start date
14/02/2017
Recruitment end date
01/09/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
University Hospital Birmingham NHS Foundation Trust
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Trial participating centre
University College London Hospital
250 Euston Road
London
NW1 2PG
United Kingdom
Sponsor information
Organisation
NHS Blood and Transplant
Sponsor details
500 North Bristol Park
Filton
Bristol
BS34 7QH
United Kingdom
+44 117 921 7501
research.office@nhsbt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
NHS Blood and Transplant
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results from different centres will be analysed together and published as soon as possible. Individual clinicians must not publish data concerning their patients that are directly relevant to questions posed by the study until the Trial Management Group has published its report and the main findings of the trial have been published. The Trial Management Group will form the basis of the Writing Committee and advise on the nature of publications. The main form of dissemination will be through publications including abstract presentations at meetings/conferences.
IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/10/2019
Participant level data
Other
Basic results (scientific)
Publication list