TREATT: a phase 3 trial testing tranexamic acid to reduce bleeding after chemotherapy

This trial is for anyone having high-dose chemotherapy, not just people with lymphoma.


Purpose of trial

The aim of this trial is to see if taking a drug called tranexamic acid regularly when platelet counts are low can reduce episodes of bleeding and the need for blood transfusions in people having high-dose chemotherapy.

When you have high-dose chemotherapy, your blood counts fall, often to a very low level. They usually start to recover within a few days but it can take longer. While platelet counts are low, you are at higher risk of complications of bleeding. You might have nose bleeds or your skin might bleed more easily. Occasionally, symptoms can be more severe, for example bleeding when you vomit.


Treatments

Tranexamic acid is also known as Ponstan. It helps to stop blood clots being broken down and has been in use for many years. Doctors use it to help stop bleeding after surgery, to reduce heavy periods and when patients develop bleeding following unexpected trauma (accidents).

This is a randomised trial. Participants are randomised (like tossing a coin) to receive tranexamic acid or a dummy drug (placebo). You can’t choose which treatment you have and neither can your doctor.

This is a blinded trial, which means you won’t know what treatment you are having.

After your high-dose chemotherapy, you have regular blood tests. When your platelet count falls below a certain point, you have an intravenous drip (into the vein) of tranexamic acid or the dummy drug three times a day, depending on which trial group you are in.

After a few days, you can take tablets three times a day by mouth instead of as a drip.

You have this treatment until your platelet count starts to recover or for a total of 30 days.

A member of the trial team checks on you every day, including examining the inside of your mouth and your skin for signs of bleeding.

When you go home, you get a diary to record any signs of bleeding. The trial team contact you a month after this treatment to see how you are. You also have a questionnaire to complete before you start treatment and again 12 weeks later.


Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

Around 616 people are needed internationally for this trial.

You may be able to enter if:

  • You have any type of lymphoma that needs treating with high-dose chemotherapy.
  • You are due to have high-dose chemotherapy or a stem cell transplant as part of your treatment.
  • You are expected to have a low platelet count for 5 days or more after your treatment.
  • You are 18 or over.

You will not be able to enter if:

  • You have or have had any problems with blood clots, including heart attack.
  • You have visible blood in your urine or are not producing enough urine at the time of joining the trial.
  • You are having other treatment that might interfere with the study treatment, including treatment within another clinical trial.
  • You are pregnant.
  • You are allergic to tranexamic acid or similar drugs (this is very rare).

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03136445.