A trial looking at when to give blood transfusions for acute myeloid leukaemia (REAL)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia

Status:

Closed

Phase:

Other

Chemotherapy can cause a drop in your red blood cells and you need a blood transfusion to bring them up again. This study is for people who are having chemotherapy for acute myeloid leukaemia (AML).

More about this trial

Red blood cells contain haemoglobin which carries oxygen around your body. A drop in red blood cells can cause tiredness and breathlessness which can affect your quality of life Open a glossary item.

To find out if you need a blood transfusion Open a glossary item a blood test is done to check your haemoglobin (Hb). You usually have a transfusion when your Hb drops to 80g/l or lower. But this can vary.

Researchers want to see if keeping your Hb level higher or lower makes any difference to how you feel and your general well being.

They also think that having more transfusions during chemotherapy for AML might make you feel better. But they don’t know for sure.

The best way to find this out is in a large clinical trial Open a glossary item. But first the researchers need to do a small feasibility study to help them decide if a larger clinical trial is possible.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if all of the following apply. You

You cannot join this study if any of these apply.

  • You have acute promyelocytic leukaemia (AMPL)
  • You have had a previous diagnosis of myelodysplastic syndrome (MDS) before AML
  • Your haematology doctor doesn’t think the study is suitable for you because either giving you too many or not enough blood transfusions could be harmful

Trial design

This is a feasibility study. The researchers need 36 people to join.

This is a randomised study. Everyone is put into 1 of 2 groups by a computer. Neither you or your doctor can choose which group you are in.

When you come in for a blood transfusion your doctor and nurses will know what your haemoglobin is and which group you are in. But they won’t be able to tell you. This is called a blind study. 

Group A
During your first cycle of chemotherapy you have a blood transfusion if your haemoglobin is 70g/l or lower.

During your 2nd cycle of chemotherapy you have a blood transfusion if your haemoglobin is 90g/l or lower.

Group B
During your first cycle of chemotherapy you have a blood transfusion if your haemoglobin is 90g/l or lower.

During your 2nd cycle of chemotherapy you have a blood transfusion if your haemoglobin is 70g/l or lower.

REAL Trial Diagram

Quality of life
You fill in a questionnaire:

  • at the start of the study
  • halfway through the 1st cycle of chemotherapy
  • at the start of the 2nd cycle of chemotherapy
  • halfway through the 2nd cycle of chemotherapy
  • just before your 3rd cycle of chemotherapy

The questions are about how you feel and what you are able to do. This is called a quality of life questionnaire.

Blood samples
The team will take a blood sample before each blood transfusion you have. This is to check your level of haemoglobin. This is a routine procedure done before any transfusion.

Hospital visits

You see the doctor or nurse for the study:

  • on the day you agree to be in the study
  • just before your 2nd cycle of chemotherapy
  • just before the start of your 3rd cycle of chemotherapy

During these visits they will:

  • do a physical examination
  • check your blood test results
  • look at your medical notes
  • ask about any problems you might have

You might be a patient in the hospital when these visits are due. If not these will fit in with your routine clinic appointments.

Side effects

There is a very small risk of getting an infection from the blood transfusion or having an allergic reaction.

Your doctor will talk to you about these risks before you agree to have a blood transfusion. 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Simon Stanworth

Supported by

NHS Blood and Transplant (NHSBT)

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14562

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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