RecruitingPHASE3INTERVENTIONAL

PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)

If you've had a severe head injury, there's a risk of dangerous blood clots forming in your legs, which can then travel to your lungs. Doctors normally give blood-thinning medicines to prevent these, but for head injuries, they're worried about more bleeding in the brain. This study, called PROTEST, aims to find the safest way to prevent these clots. We're comparing two approaches: one group will have special compression cuffs on their legs (like a gentle, automated massage), and another group will have the cuffs plus a blood-thinning medicine called Dalteparin. By doing this, we hope to learn how to best protect head injury patients from clots, without increasing the risk of brain bleeding. We want to find the best care for people like you.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

1,100

Start

19 Jul 2018

Estimated completion

01 Dec 2027

Traumatic Brain Injury

What is this study about?

When someone has a serious head injury, their body is already going through a lot. One hidden danger is the chance of blood clots forming, usually in the legs. These clots can be very serious if they travel to the lungs, an issue called a venous thromboembolism (VTE). Normally, hospitals give medicines to thin the blood and stop these clots. However, when someone has a major head injury, doctors worry that these blood-thinning medicines might make any bleeding in the brain worse.

To try and prevent these clots without medication, hospitals often use special cuffs that fit around the legs. These cuffs gently squeeze and release, helping the blood flow better and reducing the chance of clots forming. This study wants to find out if adding a blood-thinning medicine called Dalteparin to these leg cuffs is safe and more effective for people with severe head injuries, or if using just the leg cuffs is enough.

This study is comparing two ways to prevent clots: one group will only use the leg cuffs, and another group will use the leg cuffs along with Dalteparin. By looking at the results from many patients, the doctors hope to find the best way to prevent dangerous blood clots after a head injury. Their goal is to make sure you get the best possible care, keeping you safe from clots while also protecting your brain.

Key takeaways

The PROTEST study aims to find the best way to prevent dangerous blood clots after a severe head injury.
It compares leg cuffs alone vs. leg cuffs plus a blood-thinning medicine (Dalteparin).
The main goal is to prevent clots without increasing brain bleeding.
Participation involves being randomly assigned to one of two treatment groups.
Close monitoring for clots and bleeding is a key part of the study.
You can withdraw from the study at any time without affecting your NHS care.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently had a moderate or severe head injury. This is generally defined by how alert you are (using something called a Glasgow Coma Scale, or GCS) or if scans show some bleeding in your brain and you need breathing support.

There are also some reasons why you might not be able to join. For example, if you are allergic to Dalteparin or similar blood-thinning medicines, or if you have certain serious medical conditions such as existing major bleeding problems, severe or uncontrolled high blood pressure, or active stomach ulcers. We also can't include you if you are pregnant or have certain other specific health issues.

It's important that you could start the study medicine within three days of your injury, and that you can comfortably wear the special leg cuffs.

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?
Did you recently have a moderate or severe head injury?
Can you start the study treatment within three days of your injury?
Are you able to wear special leg cuffs if needed?
Have you been told you don't have any serious bleeding problems or uncontrolled high blood pressure?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups. One group will receive the special leg cuffs to help blood flow, and the other group will get the leg cuffs plus a blood-thinning injection called Dalteparin. Neither you nor your doctors will know which treatment group you are in. Throughout your time in the study, doctors and nurses will closely monitor you to check for any new blood clots or any signs of bleeding in your brain. They will also collect information about your recovery. The total time you'll be involved in the study will depend on your hospital stay and recovery.

Potential risks and benefits

Taking part in this study might mean you receive the best possible treatment to prevent blood clots after a severe head injury. However, like all medical treatments, there are potential risks. The main concern with blood-thinning medicine like Dalteparin is an increased risk of bleeding, especially in the brain for head injury patients. The study is designed to carefully monitor for these risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Foothills Medical Centre
Verified postcode
Calgary, Canada· Recruiting
Royal Alexandra Hospital
Verified postcode
Edmonton, Canada· Recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting
Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting
Queen Elizabeth II Health Sciences Centre
Verified postcode
Halifax, Canada· Recruiting
Hamilton Health Sciences Centre
Verified postcode
Hamilton, Canada· Recruiting
Kingston General Hospital
Verified postcode
Kingston, Canada· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting
Sunnybrook Health Science Centre
Verified postcode
Toronto, Canada· Recruiting
Unity Health Toronto
Verified postcode
Toronto, Canada· Recruiting
Hopital de L'Enfant-Jesus
Verified postcode
Québec, Canada· Recruiting
Royal University Hospital
Verified postcode
Saskatoon, Canada· Recruiting

Common questions

What is a 'blood clot' and why is it dangerous?

A blood clot is a lump of blood that forms. In this study, we're talking about clots that can form in your legs, which can be dangerous if they travel to your lungs and block blood flow.

What is Dalteparin?

Dalteparin is a medicine that helps to thin your blood, making it less likely for dangerous clots to form. It's often given as an injection.

What are the 'leg cuffs'?

These are special devices worn on your legs that gently squeeze and release, like a soft massage. They help to keep your blood flowing well in your legs and prevent clots.

Who pays for my treatment if I'm in the study?

All treatments and care you receive as part of this study will be covered. You won't have to pay for anything extra related to your participation.

Can I leave the study at any time?

Yes, completely. You have the right to withdraw from the study at any point, and it won't affect the care you receive from your medical team.

How to find out more

Farhad Pirouzmand, MD, MSc, FRCSC

farhad.pirouzmand@sunnybrook.ca 416-480-6100 Official trial record

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