Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of tranexamic acid for low platelet counts (TREATT)
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This trial is looking at using a drug called tranexamic acid to treat low platelet counts caused by cancer. The trial is open to people with a haematological malignancy and who are having treatment with high dose chemotherapy or a stem cell transplant.
More about this trial
Bleeding can be a problem for people with a haematological malignancy. This could be because of the cancer itself or from treatment such as high dose chemotherapy or stem cell transplant.
Doctors sometimes give these people a platelet transfusion before starting treatment to try and stop the possibility of bleeding. Tranexamic acid is a drug that can treat or prevent blood loss. It is used in surgery and other medical conditions where bleeding can be a problem. The trial team think it may help people with haematological malignancies.
In this trial the researchers will do blood tests to check on the number of platelets in your blood. When the platelets drop below a certain level you will have either the tranexamic acid or a dummy drug (placebo). You may also have a platelet transfusion if necessary. You will have this alongside the treatment you are having for your cancer.
The aims of this trial are to find out
- If tranexamic acid can reduce bleeding for people with haematological malignancies
- If the need for platelet transfusions is reduced
- How this affects quality of life
Who can enter
You may be able to join this trial if all of the following apply
- You have a cancer of the bone marrow or lymphatic system (a haematological malignancy)
- You are currently having, or about to have, high dose chemotherapy or a stem cell transplant to treat your cancer
- Your kidneys work well enough (the trial doctor will test for this)
- You are at least 18 years old
You cannot join this trial if any of these apply
- You have a type of acute myeloid leukaemia called acute promyelocytic leukaemia and are having chemotherapy to get rid of it (induction chemotherapy)
- You have had a medical condition called thrombocytopenia purpura or haemolytic uremic syndrome (your doctor can confirm this)
- You have a medical condition called disseminated intravascular coagulation (DIC). Your doctor can tell you this
- You are having a chemotherapy drug called asparaginase
- You have, or had, other problems that affect your blood, such as blood clots, or problems with your heart or veins that affects how your blood flows around your body (the trial team can advise you about this)
- You are taking medication, such as warfarin, to stop your blood clotting
- You are taking medication, such as aspirin, to stop your platelets working
- Blood can be seen in your urine
- You have had convulsions, epilepsy, fits or seizures in the past
- You are already taking part in a trial that is similar (the trial team can advise you about this)
- You are allergic to tranexamic acid
- You are pregnant or breastfeeding
This is an international phase 3 trial. The researchers need 616 people to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
You will be entered into the trial and have daily blood tests to check the number of platelets in your blood. When your platelet count drops to a certain level you will be put into 1 of the 2 treatment groups.
- People in one group have tranexamic acid
- People in the other group have a dummy drug (placebo)
When you start treatment depends on your platelet count. This could be as soon as you agree to join the trial or a short while afterwards.
To begin with you have tranexamic acid or the dummy drug as an injection into a vein 3 times a day. When you are well enough you can change to having 3 tablets 3 times a day.
You have treatment for up to 30 days as long as it is helping you and your platelet count remains low. If you leave hospital before the end of the 30 days you will have tablets to take at home.
During treatment a member of the trial team will see you every morning to ask a few questions about any signs or symptoms of bleeding. They will also look at your skin and in your mouth. If you go home before finishing treatment, you have a simple diary card to fill in each day to record any signs or symptoms of bleeding.
The trial team will ask you to fill out a questionnaire:
- when you are put into your group (randomised)
- 12 days after starting treatment
- about 1 month after starting treatment
- about 4 months after starting treatment
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You continue to have your usual treatment for your haematological malignancy alongside the trial treatment.
It is likely you will be in hospital for the start of the trial treatment.
A month and 3 months after treatment, a member of the team will see you in hospital, or phone you, to see how you are.
Tranexamic acid is used in other medical conditions that can cause bleeding. Although it may cause unwanted blood clots this has not been a problem in these conditions. When used for a short time there have been no reported side effects.
The trial team are not certain if this will be the same for someone with your condition. So the trial team, your doctor and the nurses will monitor you carefully for blood clots and any other problems.
How to join a clinical trial
Dr Lise Estcourt
Dr Simon Stanworth
NIHR Clinical Research Network: Cancer
NHS Blood and Transplant (NHSBT)