Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study
This study focuses on people with cancer who are taking blood-thinning medicines called DOACs. These patients often need a special tube, called a Central Venous Catheter (CVC), inserted into a large vein, usually in the chest. Doctors often aren't sure whether to stop these blood thinners for a short time before the procedure or to continue taking them. The study aims to find out which approach is better to prevent problems like bleeding or blood clots around the time of the CVC insertion. This is a first step to help doctors agree on the best way to manage DOACs for cancer patients during these common procedures.
At a glance
What is this study about?
Imagine you have cancer and need a special tube, called a Central Venous Catheter (CVC), placed into a large vein to help with treatments or tests. Perhaps you're also taking blood-thinning medicines called Direct Oral Anticoagulants (DOACs) to prevent or treat blood clots, which can be common in cancer patients.
Now, here's the puzzle: when it's time for your CVC to be put in, your doctors need to decide if you should stop taking your DOACs for a short while beforehand, or if it's safer to keep taking them. This decision is tricky because stopping DOACs might increase your risk of blood clots, but continuing them could increase your risk of bleeding during or after the procedure. Because cancer patients sometimes have different risks for bleeding and clotting compared to other people, doctors don't always agree on the best approach.
This study, called VENOCAT, is a pilot (a small, first-step study) that aims to figure out the best way to manage DOACs around the time a CVC is inserted for cancer patients. By comparing two groups – one continuing their DOACs and one stopping them briefly – the researchers hope to gather important information. This will help them plan a larger study in the future to establish clear guidelines for doctors, ultimately making these procedures safer and more straightforward for people like you.
Key takeaways
- This study helps decide how to manage blood thinners (DOACs) for cancer patients.
- It's about inserting a special catheter (CVC) into a vein.
- Two approaches are being compared: continuing DOACs vs. briefly stopping them.
- The goal is to reduce risks like bleeding and blood clots.
- This is a first step to set clear guidelines for future patient care.
Who may be eligible?
To be considered for this study, you would need to be an adult who is currently taking a blood-thinning medicine (a DOAC) for a blood clot (VTE) or an irregular heartbeat (Atrial Fibrillation). You also need to have active cancer, which means you've been diagnosed recently, have cancer that has come back or spread, or have had treatment within the last six months, or have a blood cancer that isn't fully in remission.
You would also be someone who is scheduled to have a special tube, called a Central Venous Catheter (CVC), inserted by a doctor using imaging guidance. It's important that you are willing and able to follow the study's instructions for managing your blood-thinning medicine and attending follow-up appointments.
However, you would not be able to join if your kidneys aren't working well enough (as measured by a specific blood test), if you've been diagnosed with a new blood clot in the past three weeks, if your platelet count (a type of blood cell important for clotting) is too low, or if you're taking other medicines that could dangerously interact with your DOACs.
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 an adult taking a DOAC for blood clots or an irregular heartbeat?
- Do you have active cancer?
- Are you scheduled to have a CVC inserted?
- Are your kidneys generally healthy (no severe kidney problems)?
- Have you not had a new blood clot diagnosis in the last three weeks?
- Are your blood clotting cells (platelets) at a healthy level?
What does participation involve?
If you join this study, you will be assigned to one of two groups by chance, like flipping a coin. One group will continue taking their blood-thinning medicine (DOAC) around the time of your CVC insertion, while the other group will stop taking it briefly before and after the procedure, as guided by the study doctors. You will have regular contact with the study team to monitor your health and ensure the DOAC management plan is followed carefully.
The study will involve monitoring for any bleeding or clotting problems that might occur after your CVC is put in. This will help doctors understand which approach is safer. The total duration of your participation will depend on how long you need to be monitored after your CVC insertion, but it will involve careful management and follow-up during this key period.
Potential risks and benefits
Locations (1)
- University Health NetworkVerified postcodeToronto, Canada
Common questions
What is a DOAC?
DOAC stands for Direct Oral Anticoagulant. It's a type of medicine that thins your blood to prevent or treat blood clots, and it's taken as a pill.
What is a CVC?
CVC stands for Central Venous Catheter. It's a thin, flexible tube placed into a large vein, usually in the neck or chest, to give medicines, fluids, or take blood samples.
Why is it tricky to manage DOACs around CVC insertion?
It's tricky because cancer patients have a higher risk of both bleeding and blood clots. Doctors need to find the right balance – stopping DOACs might cause clots, but continuing them could cause bleeding during the procedure.
What does 'pilot study' mean?
A pilot study is a small, initial study designed to test if a larger study is possible and to gather some early information. It's like a practice run before the main event.
Will I know if I'm continuing or stopping my DOAC?
Yes, you will be told which group you are in (continuing or briefly stopping your DOAC) and given clear instructions on how to manage your medication.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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