RecruitingPHASE4INTERVENTIONAL

STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis

Cancer patients can get blood clots, which are usually treated with medicines called blood thinners. However, these medicines can cause bleeding. This is a bigger worry for cancer patients who also have low numbers of platelets, tiny cells that help blood to clot and stop bleeding. Low platelets can be caused by cancer or its treatments. Doctors aren't sure of the best way to treat blood clots in these patients. This small study, called a "pilot study," will help us plan a larger study. We'll include 50 patients with cancer, low platelets, and a recent blood clot. They'll be randomly given one of two treatments: a full dose of blood thinners plus platelet transfusions, or a lower dose of blood thinners without transfusions. We'll follow them for 30 days to see which treatment works best and to prepare for a bigger trial.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Tzu-Fei Wang

Enrolment target

Start

29 Aug 2022

Estimated completion

31 Jan 2027

Cancer-associated Thrombosis Thrombocytopenia

What is this study about?

When people have cancer, they sadly have a higher chance of developing blood clots. These clots usually need treating with medicines known as blood thinners, which stop the blood from clotting too much. However, a common side effect of blood thinners is bleeding. This can be particularly concerning for cancer patients who also have a low number of platelets in their blood. Platelets are like tiny little helpers in your blood that form a plug to stop bleeding, so when their numbers are low, you're at a higher risk of bleeding.

Many cancer patients have low platelet counts. This can be due to the cancer itself or from the treatments they receive. Because of this, doctors are currently unsure what the safest and most effective way is to treat blood clots in cancer patients who also have low platelets. This is a big question that needs an answer to improve care for these patients.

This study, called START, is a small initial step, known as a 'pilot study'. Its main goal is to help us work out the best way to run a much larger study in the future. We will involve 50 cancer patients who have had a new blood clot and have low platelet counts. They will be split into two groups by chance: one group will receive a normal dose of blood thinners along with extra platelets given as a transfusion, while the other group will receive a lower dose of blood thinners without extra platelets. We will watch these patients closely for 30 days to see how each treatment works. If this pilot study goes well, it will pave the way for a bigger trial that will give us clear answers on the best treatment strategy for these patients.

Key takeaways

This study focuses on treating blood clots in cancer patients with low platelets.
It compares two ways of using blood thinners, with or without extra platelets.
The study helps doctors understand the safest and best treatment approach.
It's a small 'pilot study' to prepare for a larger, more detailed trial.
Participation involves random assignment to a treatment group and 30 days of follow-up.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with cancer or are currently being treated for it, or whose cancer has returned in the last six months. They need to have recently developed a blood clot (within the last 14 days) that doctors plan to treat with blood thinners. Crucially, they must also have a low platelet count (meaning fewer than 50,000 platelets per microliter of blood) due to their cancer or its treatment.

However, this study won't be suitable for everyone. You wouldn't be able to join if you've already been taking blood thinners for your current blood clot for more than three days while having low platelets. Also, if your blood clot is only in a vein close to the skin's surface, or if doctors believe you have less than one month to live, you wouldn't be eligible.

Additionally, conditions like severe kidney problems, certain other causes of low platelets (not related to cancer or its treatment), or a known allergy to heparin (a type of blood thinner) would prevent you from taking part. If you cannot receive blood products, or if taking any dose of blood thinners is considered too risky for you (for example, if you have active bleeding or a bleeding disorder), then this study would not be right for you.

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?
Have you been diagnosed with cancer or treated for it recently?
Have you had a new blood clot in the past two weeks?
Do you have a low platelet count (below 50,000)?
Are you able to agree to take part in the study in writing?
Do you have any serious kidney problems or other conditions that might prevent you from taking blood thinners?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of two treatment groups. One group will receive a standard dose of blood thinners along with platelet transfusions (where extra platelets are given to you), and the other group will receive a reduced dose of blood thinners without platelet transfusions. The specific blood thinner medicines used will be Enoxaparin, Dalteparin, or Tinzaparin, which are all commonly used to treat blood clots.

During the study, you will be followed closely for 30 days after you start treatment. This will involve regular check-ups and assessments to monitor your health, how effectively the treatment is working, and to watch for any side effects, especially bleeding. The study team will explain all the visits, what tests will be done, and for how long. The total duration of active follow-up for the study will be 30 days.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving close medical monitoring. We hope the information gained from this study will help doctors find the best and safest way to treat blood clots in cancer patients with low platelets in the future. However, there are also potential risks; for example, both treatment approaches involve blood thinners, which carry a risk of bleeding. If you are in the group receiving platelet transfusions, there are also general risks associated with receiving blood products. You will be fully informed about all potential risks and benefits before deciding to join, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (4)

University of Alberta
Verified postcode
Edmonton, Canada· Withdrawn
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting
Niagara Health - St. Catharines Site
City only
Saint Catharines, Canada· Recruiting
Windsor Regional Hospital
Verified postcode
Windsor, Canada· Recruiting

Common questions

What are blood clots and why are they a problem for cancer patients?

Blood clots are clumps of blood that form in your veins. For cancer patients, they are more common and can be serious, sometimes blocking blood flow and needing treatment with blood-thinning medicines.

What are platelets?

Platelets are tiny cells in your blood that help it to clot and stop bleeding if you get a cut or bruise. If you have low numbers of platelets, you are at a higher risk of bleeding.

What does 'randomly assigned' mean?

It means you will be put into one of the treatment groups by chance, like flipping a coin. This helps make sure the study results are fair and reliable.

What is a 'pilot study'?

A pilot study is a small, initial study designed to test if a larger study is possible and to help plan it properly. It's like a practice run for a much bigger trial.

Will my regular cancer treatment be affected?

The study focuses on treating your blood clot. Any potential interactions or effects on your ongoing cancer treatment will be carefully considered and discussed with you by the study team and your doctors.

How to find out more

Jennifer Brinkhurst

jbrinkhurst@ohri.ca +16137378899 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.