RecruitingPHASE3INTERVENTIONAL

Heparin vs Placebo for Cardiac Catheterization

This study is comparing different amounts of a medicine called heparin to a dummy medicine (placebo) in people who are having a 'cardiac catheterisation'. This is a procedure where a thin tube is put into a blood vessel, usually in the wrist, to check the heart. The researchers want to find out if giving heparin can reduce the chance of bruising or blocking the blood vessel in the wrist after the procedure. Patients will be put into one of three groups by chance: no blood-thinner, a small dose of blood-thinner, or a higher dose. The study aims to make this common heart test even safer and more comfortable for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

1,623

Start

05 Oct 2020

Estimated completion

01 Dec 2026

Cardiac Disease

What is this study about?

When you have a cardiac catheterisation, doctors put a very thin tube, called a catheter, into a blood vessel, often in your wrist, to look at your heart. Sometimes, after this, the blood vessel can bruise or even get blocked, which can be uncomfortable. This study is looking at a medicine called heparin, which is a 'blood-thinner'. It helps stop your blood from clotting too much.

The main idea is to see if giving a small amount of heparin, or a slightly larger amount, can help prevent these problems when the catheter is taken out. Researchers want to compare this to not giving any heparin at all. By doing this, they hope to find the best way to keep your wrist healthy and comfortable after your heart test.

This is important because millions of people have cardiac catheterisations every year. If we can find a simple way to reduce problems like bruising or blockages, it could make a real difference to patient care and recovery for many people across the country.

Key takeaways

Study compares different heparin doses vs no heparin.
Aims to reduce bruising and blood vessel problems after heart tests.
Participants are randomly assigned to one of three groups.
Focuses on immediate effects after a wrist-based heart catheterisation.
Participation is voluntary and does not affect your medical care.

Who may be eligible?

To join this study, you must be at least 18 years old and scheduled to have a routine heart investigation called a 'diagnostic cardiac catheterisation'. This procedure needs to be done through a blood vessel in your wrist, and doctors will check that the blood flow in your hand and wrist is normal before you can take part.

You won't be able to join the study if you've had problems with blood flow in your hand or arm before, or if you've had surgery very close to where the catheter goes in. Also, if you need an urgent heart catheterisation, or if you know you're allergic to heparin, this study won't be suitable for you.

Finally, if you already need to take blood-thinning medication for another health reason, or if you've had a specific type of reaction to heparin in the past (called HIT), then you wouldn't be able to take part.

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?
Are you having a routine heart investigation through your wrist?
Do you have normal blood flow in your hand and wrist?
Are you not allergic to heparin or do you have a history of HIT?
Do you not currently need to take blood-thinning medication for another reason?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of three groups, just like drawing straws. You might receive a small dose of the blood-thinner heparin, a higher dose of heparin, or a salt water solution that has no active medicine (like a dummy treatment). This will be given to you during your heart catheterisation.

After your procedure, a special wristband will be gently loosened over about 30 minutes. The study team will then check your wrist for any bruising or if the blood vessel has become blocked. You won't need any extra visits beyond your normal care, and the study will focus on what happens during and immediately after your heart catheterisation.

Potential risks and benefits

There's a chance that taking part in this study could lead to less bruising or fewer blood vessel problems after your heart catheterisation. However, taking blood-thinners can carry a small risk of bleeding. You will be closely monitored. Remember, you can choose to leave the study at any time, for any reason, and this won't affect your medical care.

Locations (2)

Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is a cardiac catheterisation?

It's a common heart test where doctors put a thin tube into a blood vessel, often in your wrist, to get a closer look at your heart.

What is heparin?

Heparin is a medicine that helps to thin your blood, making it less likely to form clots.

Will I know if I'm getting heparin or the dummy treatment?

No, you won't know which treatment you're getting. This helps us find out the true effects of the medicine.

What if I have an allergic reaction to heparin?

Before you take part, doctors will ask if you have any known allergies to heparin. If you do, you won't be able to join the study.

Can I still have my heart procedure if I don't join the study?

Absolutely. Joining is completely your choice, and your heart care will not be affected if you choose not to take part.

How to find out more

Shahar Lavi, MD

shahar.lavi@lhsc.on.ca 519-6633611 Official trial record

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