AuthorisedPhase II and Phase III (Integrated)Interventional

Intermediate versus standard dose enoxaparin to prevent venous thromboembolism in severe trauma patients: a multicenter double blind randomised controlled trial (HEPTRAUMA)

This study, called HEPTRAUMA, is for people who have had severe injuries. When you have a serious injury, you're at a higher risk of developing dangerous blood clots in your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE). This trial is testing two different doses of a common blood-thinning medicine called Lovenox (also known as enoxaparin) to see which dose is better at preventing these clots. Researchers want to find a dose that is effective at stopping clots but doesn't cause too much bleeding, which can be another serious problem after an injury. This is a double-blind study, meaning neither the patient nor their doctor will know which dose they are receiving, so the results are as fair as possible.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

540

Start

11 Dec 2025

Severe trauma

What is this study about?

When someone has a severe injury, their body's natural response can sometimes lead to the formation of blood clots. These clots can be very dangerous if they travel to the lungs, causing a pulmonary embolism (PE), or if they develop in deep veins, often in the legs, known as deep vein thrombosis (DVT). Medicines that thin the blood are often used to prevent these clots, but finding the right balance is tricky. You want enough medicine to stop clots, but not so much that it causes excessive bleeding, which can be another serious complication after an injury.

This study, called HEPTRAUMA, is designed to compare two different doses of a commonly used blood-thinning medicine called Lovenox (or enoxaparin). One dose is the standard amount that doctors usually give, and the other is an intermediate dose, which is slightly higher. By comparing these two, doctors hope to learn if the intermediate dose is more effective at preventing blood clots without significantly increasing the risk of bleeding.

The trial is 'double-blind', which means neither you nor your doctors will know whether you are receiving the standard or intermediate dose. This helps ensure that the results are based purely on the medicine's effect. The main things researchers will be looking at are whether you develop a DVT or PE within 14 days of starting the study, and also checking for any major bleeding. The information gathered from this study will help doctors in the future decide the best way to prevent blood clots in other patients with severe injuries.

Key takeaways

This study compares two doses of a blood thinner (Lovenox) after severe injury.
It aims to find the best dose to prevent dangerous blood clots (DVT, PE).
Researchers will also be watching for any bleeding caused by the medicine.
Participation involves receiving one of two doses, with close monitoring.
The study helps improve future care for people with severe injuries.

Who may be eligible?

This study is looking for adults who have experienced a severe injury. Anyone aged 18 years or older can potentially take part. The study is open to both men and women.

There might be certain health conditions or other treatments that could prevent someone from joining the study, but these details would be discussed fully by the study team. Usually, you need to be well enough to receive treatment and able to follow the study's instructions.

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 recently experienced a severe injury?
Are you currently receiving treatment in a hospital setting?
Are you able to provide consent (or have someone legally able to provide it for you)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of two doses of the blood-thinning medicine Lovenox. This medicine is given as an injection. Neither you nor your care team would know which dose you are receiving. Over the first 14 days, the study team would carefully monitor you for any signs of new blood clots or any bleeding events. They would also collect information about your overall health and recovery. There would be follow-up checks, and they would also check on your health status 30 days after you started the treatment. The total duration of active research monitoring would be at least 30 days.

Potential risks and benefits

Taking part in this study might offer the potential benefit of closer monitoring for blood clots and bleeding. The main goal is to help future patients, but you might personally benefit from being on a dose of Lovenox that could be more effective. However, there are potential risks, primarily related to the Lovenox itself, such as an increased risk of bleeding. This bleeding could range from minor bruising to more serious events. The study team will carefully monitor you for these risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is DVT and PE?

DVT (Deep Vein Thrombosis) is a blood clot in a deep vein, usually in the leg. PE (Pulmonary Embolism) happens when a clot from elsewhere travels to the lungs, which can be very serious.

What is Lovenox?

Lovenox (also known as enoxaparin) is a medicine used to thin the blood and prevent blood clots from forming or growing larger. It's given by injection.

What does 'double-blind' mean?

Double-blind means that neither you nor your doctors will know which dose of Lovenox you are receiving in the study. This helps make the study results as fair and unbiased as possible.

How long will I be involved in the study?

You'll be closely monitored for blood clots and bleeding for 14 days after starting the medicine, and your health will be checked again 30 days after you began the study treatment.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without it affecting your medical care or relationship with your doctors.