Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia
This study is exploring a common problem for people with blood cancers called Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) – bleeding. These cancers can make it harder for your blood to clot properly, leading to bleeding that can be serious and affect your daily life. The research is testing a medicine called tranexamic acid, which is already used for bleeding in other situations. Half of the people taking part will receive this medicine, and the other half will get a placebo (a dummy pill with no active medicine). We'll then compare the two groups to see if tranexamic acid can safely reduce how often or how severely people bleed. If it works, it could help many patients worldwide.
At a glance
What is this study about?
Blood cancers like Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) can be very challenging. One common issue for people living with these conditions is bleeding. This happens because the cancer can affect how your blood clots, making you more prone to bleeding and bruising. These bleeding problems can sometimes be severe enough to need a hospital stay and can really impact how you feel day-to-day.
This study is looking for ways to help manage these bleeding issues. We are focusing on a medicine called tranexamic acid, which is known to help prevent blood clots from breaking down. While this medicine is used in other areas of medicine, it hasn't been fully studied for people with MDS and AML who are receiving chemotherapy as an outpatient (meaning you don't have to stay in hospital).
The main goal is to see if tranexamic acid can safely and effectively reduce bleeding in people with MDS and AML. Half of the people who join the study will get the actual medicine, and the other half will get a placebo, which looks identical but contains no active drug. This allows the researchers to fairly compare the effects. If this medicine proves helpful and safe, it could become a widely used and affordable way to improve the quality of life for many patients facing these challenging blood cancers.
Key takeaways
- Tests if tranexamic acid can reduce bleeding in MDS/AML.
- Compares the medicine to a dummy pill (placebo).
- Aims to improve quality of life for patients.
- Involves regular check-ups alongside your usual care.
- Could lead to a widely available treatment if successful.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a diagnosis of Myelodysplastic Syndromes (MDS), an overlapping condition called myelodysplastic/myeloproliferative neoplasm, or Acute Myeloid Leukemia (AML).
Additionally, you should be receiving a type of less-intensive chemotherapy (which could be for newly diagnosed cancer or if it has come back) and have a low number of platelets in your blood. Platelets are tiny cells that help your blood clot, so low numbers can increase the risk of bleeding.
There are also some reasons why you wouldn't be able to join. For example, if your medical team thinks you're unlikely to live longer than 30 days, or if you can't give your clear permission to take part. You also can't participate if you have a known allergy to tranexamic acid, active blood clots, certain heart problems, severe kidney disease, or if you are pregnant or breastfeeding.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)?
- Are you having a type of less-intensive chemotherapy?
- Do you have low platelet counts?
- Are you able to give your informed consent?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned (like flipping a coin) to either receive tranexamic acid or a placebo (a dummy pill) for a certain period. Both the medicine and the placebo would be given as part of your regular outpatient chemotherapy treatment.
The researchers will closely monitor you to see if the medicine affects your bleeding, either by reducing its frequency or how severe it is. This will involve regular check-ups and assessments, likely alongside your routine clinic visits. The study aims to enrol patients over two years, but your individual participation length would be discussed in detail by the study team, along with specific visit schedules and what each visit would involve.
Potential risks and benefits
Locations (1)
- CancerCare ManitobaVerified postcodeWinnipeg, Canada· Recruiting
Common questions
What is tranexamic acid?
It's a medicine that helps prevent blood clots from dissolving, which can reduce bleeding.
Will I know if I'm getting the real medicine or the placebo?
No, it's a 'blinded' study, meaning neither you nor your doctors will know which you're receiving until the study is over. This ensures fair results.
How long will I be in the study?
The exact length of your participation would be discussed by the study team, but the overall study is expected to enrol patients for two years.
What are the main risks of taking tranexamic acid?
The study will review known side effects, but generally, it can slightly increase the risk of blood clots. Your doctors will check if it's safe for you.
Can I stop participating at any time?
Yes, you are free to leave the study at any point without it affecting your medical care.
How to find out more
Brett Houston, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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