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
Contact information
Mrs Heather Smethurst
Public
Public
Clinical Trials Unit
NHS Blood & Transplant
Cambridge Blood Donor Centre
Long Road
Cambridge
CB2 0PT
United Kingdom
| Phone | +44 7471 147896 |
|---|---|
| heather.smethurst@nhsbt.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | REd cell transfusion in Acute myeloid Leukaemia (REAL) |
| Study acronym | REAL |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/04/2016 |
| Completion date | 01/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 36; UK Sample Size: 36 |
| Total final enrolment | 43 |
| Key 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) |
| Key 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. |
| Date of first enrolment | 14/02/2017 |
| Date of final enrolment | 01/09/2017 |
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
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
University College London Hospital
250 Euston Road
London
NW1 2PG
United Kingdom
London
NW1 2PG
United Kingdom
Sponsor information
NHS Blood and Transplant
Hospital/treatment centre
Hospital/treatment centre
500 North Bristol Park
Filton
Bristol
BS34 7QH
England
United Kingdom
| Phone | +44 117 921 7501 |
|---|---|
| research.office@nhsbt.nhs.uk | |
"ROR" |
https://ror.org/0227qpa16 |
Funders
Funder type
Research organisation
NHS Blood and Transplant
Government organisation / Local government
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 date | 01/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
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
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.
