A trial looking at platelet transfusions during treatment for cancer of the blood or lymphatic system (TOPPS)

Please note this trial is no longer recruiting patients.

This trial is looking at the use of platelet transfusions during chemotherapy for a haematological malignancy.

Chemotherapy can slow the production of blood cells by killing them off as they grow and divide. During chemotherapy treatment, the doctors measure the number of blood cells you have. They call this your blood count.

Platelets are one type of blood cell. They are very important in blood clotting and help to stop bleeding. If the number of platelets in your blood is low you may bruise easily, have nosebleeds or bleed more than usual from cuts or grazes. Most bleeds are small. Very occasionally the bleeding can be more serious.

When your blood tests show that your platelet count is very low, your doctors will usually give you platelet transfusions. It is like having a blood transfusion, but the fluid is clear as it contains only platelets. All the red cells and white cells have been taken out. Having a platelet transfusion to prevent bleeding is called a prophylactic transfusion. Prophylactic just means preventative.

Doctors don’t really know if it is necessary to give these preventative transfusions, and there are small risks associated with platelet transfusions. Some people have a reaction to the platelets and sometimes this can be serious. Also, there is a small risk of getting an infection from transfusions.

It may be just as safe to wait until you have early signs of bleeding, such as bleeding gums, before having a platelet transfusion. The researchers want to find out if platelet transfusions are really necessary for people who have a low platelet count, but no signs of bleeding.

The aim of this trial is to compare the different ways of using platelet transfusions. This may affect the way doctors use them in the future.

Recruitment

Start 01/08/2006

End 03/08/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have a haematological malignancy such as leukaemia or lymphoma
Are having chemotherapy that causes a low platelet count
Already have a low platelet count OR your doctors expect your platelet count to drop and stay very low for at least 5 days
Are at least 16 years old

You cannot enter this trial if you

Have acute promyelocytic leukaemia
Have already had serious bleeding during your cancer treatment
Have a clotting disorder, such as haemophilia
Take aspirin or other blood thinning drugs
Have HLA antibodies in your blood (this can happen if you have already had a lot of platelet transfusions and you can then only have platelets from a closely matched donor)
Have already taken part in this trial
Are pregnant

Trial design

This is a randomised trial. It will recruit about 600 people in the UK. Everybody taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will be on the trial for 30 days.

If you are in group A, you will have prophylactic platelet transfusions whenever your platelet count drops below a certain level. You will also have platelets if you have early signs of bleeding.

If you are in group B, you will not have platelet transfusions just because you have a very low platelet count. You will have platelets if you have early signs of bleeding.

Everybody taking part will have a blood test each day they are in hospital. This is to measure your platelet count. A specialist nurse or doctor will check you everyday for any signs of bleeding. They will look at your skin and in your mouth. If you go home when you are still on the trial, you will have some forms to fill in at home. These will ask about any signs of bleeding you have, such as nose bleeds, bleeding gums and bruising.

The trial team will record information about everybody taking part to see if the people who don’t have prophylactic transfusions have more bleeding.

Hospital visits

The trial will take place while you are in hospital having treatment, so there will be no extra hospital visits. If you go home when you are still on the trial, a research nurse will contact you and arrange to collect the diary forms you fill in at home.

Side effects

It is possible that people who do not have prophylactic platelets may have more signs and symptoms of bleeding. You can discuss what this might mean for you when you talk to the doctors about joining the trial.