Red cell transfusion in acute myeloid leukaemia (REAL)

ISRCTN ISRCTN96390716
DOI https://doi.org/10.1186/ISRCTN96390716
IRAS number 210454
Secondary identifying numbers 31999
Submission date
23/01/2017
Registration date
23/01/2017
Last edited
22/08/2022
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-when-to-give-blood-transfusions-for-acute-myeloid-leukaemia-real

Contact information

Mrs Heather Smethurst
Public

Clinical Trials Unit
NHS Blood & Transplant
Cambridge Blood Donor Centre
Long Road
Cambridge
CB2 0PT
United Kingdom

Phone +44 7471 147896
Email heather.smethurst@nhsbt.nhs.uk

Study information

Study designRandomised; Interventional; Design type: Treatment, Management of Care
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleREd cell transfusion in Acute myeloid Leukaemia (REAL)
Study acronymREAL
Study objectivesThe 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(s)Approved 24/09/2016, West Midlands - Solihull Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham NG1 6FS; +44 (0)207 104 8191; NRESCommittee.WestMidlands-Solihull@nhs.net), ref: 16/WM/0406
Health condition(s) or problem(s) studiedSpecialty: Cancer, Primary sub-specialty: Haematological Oncology; UKCRC code/ Disease: Cancer/ Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissu
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measuresAdherence 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 study start date01/04/2016
Completion date01/11/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 36; UK Sample Size: 36
Total final enrolment43
Key inclusion criteria1. 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)
Key exclusion criteria1. 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.
Date of first enrolment14/02/2017
Date of final enrolment01/09/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Queen Elizabeth Hospital
University Hospital Birmingham NHS Foundation Trust
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
University College London Hospital
250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor information

NHS Blood and Transplant
Hospital/treatment centre

500 North Bristol Park
Filton
Bristol
BS34 7QH
England
United Kingdom

Phone +44 117 921 7501
Email research.office@nhsbt.nhs.uk
ROR logo "ROR" https://ror.org/0227qpa16

Funders

Funder type

Research organisation

NHS Blood and Transplant
Government organisation / Local government
Alternative name(s)
National Health Service Blood and Transplant, UK National Health Service Blood and Transplant, NHSBT
Location
United Kingdom

Results and Publications

Intention to publish date01/10/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe 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 planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 16/02/2022 05/05/2022 Yes No
Protocol file version 2.0 09/10/2018 22/08/2022 No No
HRA research summary 28/06/2023 No No

Additional files

33122 REAL_Protocol_v2.0._09Oct2018.pdf

Editorial Notes

22/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
06/05/2022: The ethics approval has been added.
05/05/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
3. The IRAS number has been added.
4. The overall trial end date has been changed from 01/03/2019 to 01/11/2019.
08/05/2017: Cancer Help UK lay summary link added to plain English summary field
10/04/2017: Internal review
22/02/2017: Verified study information with principal investigator.