Condition category
Cancer
Date applied
23/01/2017
Date assigned
23/01/2017
Last edited
08/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

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.