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Comparing intermediate and standard doses of enoxaparin to prevent blood clots in patients with severe trauma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at people who have experienced severe trauma, which refers to serious injuries to the body that often require intensive care. After such injuries, patients are at risk of developing blood clots in their veins, a condition known as venous thromboembolism. To prevent these dangerous blood clots, doctors commonly give patients a blood-thinning medication. The study will use enoxaparin, which is a type of blood thinner that helps prevent clots from forming in the blood vessels.

The purpose of this study is to compare two different doses of enoxaparin to see which one works better at preventing major blood clots in people who have suffered severe injuries. Some patients will receive what is called an intermediate dose, which is a medium amount of the medication, while others will receive a standard dose, which is the usual amount doctors typically prescribe. Some patients will receive placebo. The study will look at whether patients develop serious blood clots such as deep vein thrombosis, which are clots that form in the deep veins of the legs, or pulmonary embolism, which are clots that travel to the lungs.

Patients in this study will receive injections under the skin of either the intermediate dose or standard dose of enoxaparin for up to 14 days while they are recovering from their injuries. During this time, doctors will carefully monitor patients for any signs of blood clots or bleeding problems. The study will also track whether patients experience any major bleeding, since blood-thinning medications can sometimes increase the risk of bleeding. All participants will be followed for 30 days after starting the treatment to see how well they recover and whether they develop any complications related to blood clots or bleeding.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Admission and enrollment

    Upon admission to the intensive care unit following a severe trauma, eligibility for the study will be assessed.

    The expected stay in the intensive care unit must be longer than 48 hours.

    Enrollment will occur if the criteria are met, including being at least 18 years of age and having affiliation to the French social security system or European health insurance.

  2. Step 2

    Random assignment to treatment group

    Following enrollment, random assignment to one of two treatment groups will occur.

    One group will receive an intermediate dose of enoxaparin, while the other group will receive a standard dose of enoxaparin.

    Enoxaparin is a medication used to prevent blood clots. It is also known as a low-molecular-weight heparin.

    Neither the patient nor the medical team will know which dose is being administered, as this is a double-blind study.

  3. Step 3

    Medication administration

    The assigned medication will be administered through subcutaneous injection, which means the injection will be given under the skin.

    The medication used is Lovenox, which contains enoxaparin sodium as the active ingredient, or a placebo solution.

    The medication will be given according to the assigned dose regimen throughout the treatment period.

    Administration will continue as planned unless bleeding complications require interruption.

  4. Step 4

    Monitoring during the first 14 days

    During the first 14 days following enrollment, close monitoring for complications will take place.

    Monitoring will focus on detecting signs of blood clots, including deep vein thrombosis (blood clots in deep veins, typically in the legs) and pulmonary embolism (blood clots that travel to the lungs).

    Monitoring will also assess for bleeding complications, including the need for procedures to stop bleeding, interruption of medication due to bleeding, or bleeding in critical organs.

    Any symptoms of blood clots or bleeding will be evaluated and managed as needed.

  5. Step 5

    Assessment at day 30

    At 30 days following enrollment, a comprehensive assessment will be conducted.

    This assessment will evaluate the occurrence of blood clots, bleeding complications, and overall health status.

    Information regarding survival will also be recorded at this time point.

Who can join the trial?

5 criteria

  • You must be an adult, which means you are 18 years of age or older
  • You must have been admitted to an intensive care unit, which is a special hospital unit for patients who need close monitoring and advanced medical care, after experiencing a severe injury
  • Your doctors expect that you will need to stay in the intensive care unit for more than 48 hours, which is more than 2 days
  • Your medical team plans to give you LMWH, which stands for low-molecular-weight heparin, a type of medication that helps prevent blood clots from forming in your veins
  • You must be covered by the French social security system or have a European Health Insurance Card, which is called CEAM

Who cannot join the trial?

12 criteria

  • Pregnant women cannot participate in this study, as pregnancy may affect blood clotting and the safety of the medication being tested.
  • Patients who are breastfeeding are not allowed to join, because the medication could pass into breast milk and affect the baby.
  • People with active bleeding that cannot be controlled are excluded, as the study medication helps prevent blood clots by thinning the blood, which could make bleeding worse.
  • Patients with a known allergy to heparin, which is the blood-thinning medication being studied, cannot take part.
  • People who have had a condition called heparin-induced thrombocytopenia in the past are excluded. This is a serious reaction where heparin causes the number of blood cells that help with clotting, called platelets, to drop dangerously low.
  • Patients with severe kidney problems cannot participate, as their body may not be able to process the medication properly.
  • People with severe liver problems are excluded, because the liver helps control blood clotting and medication processing.
  • Patients who have a brain injury with bleeding inside the skull are not allowed to join, as blood-thinning medication could worsen this bleeding.
  • People who have had surgery on their brain or spinal cord within the last three months cannot participate.
  • Patients with spinal anesthesia or an epidural catheter, which is a small tube placed in the back for pain relief, may be excluded due to bleeding risk.
  • People who are already taking other blood-thinning medications that cannot be stopped are excluded.
  • Patients with a life expectancy of less than 24 hours cannot participate in the study.
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Investigated drugs

Enoxaparin is a blood-thinning medication that helps prevent blood clots from forming in your veins. In this trial, it is being tested at different dose levels to see which dose works better at preventing dangerous blood clots in patients who have experienced severe injuries. This medication is given by injection under the skin.

What is already known about the treatment

Enoxaparin – Enoxaparin is a low-molecular-weight heparin medication that is given by injection under the skin to prevent blood clots from forming in the veins. It works by blocking certain proteins in the blood that help clots form, making it harder for dangerous clots to develop, especially in patients who are at high risk such as those who have experienced severe injuries. This medication is widely used and approved in medical practice for preventing deep vein thrombosis and pulmonary embolism in trauma patients, surgical patients, and others who are immobilized or at increased risk of clotting. In this clinical trial, researchers are comparing two different doses of enoxaparin to find out which one works better to prevent serious blood clots in people who have suffered severe trauma.

Investigated diseases

  • Severe Trauma

    Severe trauma refers to serious physical injuries to the body caused by external forces such as accidents, falls, or violent impacts. These injuries are significant enough to potentially damage multiple organs or body systems. The condition often involves broken bones, internal bleeding, or damage to vital organs. Severe trauma can lead to complications such as blood clots forming in the veins. The body's normal healing processes may be disrupted due to the extent of the injuries. Patients with severe trauma typically require immediate medical care and close monitoring during recovery.

  • Deep Vein Thrombosis

    Deep vein thrombosis occurs when a blood clot forms in a deep vein, usually in the legs. The clot can partially or completely block blood flow through the vein. Common symptoms include swelling, pain, and warmth in the affected limb. The condition can develop after periods of immobility or following injuries. If the clot breaks loose, it can travel through the bloodstream to other parts of the body. Deep vein thrombosis is more likely to occur in people who have experienced trauma or surgery.

  • Pulmonary Embolism

    Pulmonary embolism happens when a blood clot travels to the lungs and blocks one or more arteries. The clot usually originates from the deep veins in the legs or other parts of the body. This blockage prevents proper blood flow to the lung tissue. Symptoms typically include sudden shortness of breath, chest pain, and rapid heartbeat. The condition can cause the affected part of the lung to stop functioning properly. Pulmonary embolism often develops as a complication of deep vein thrombosis.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522832-16-00Protocol code38RC23.0261Estimated enrolment540 patientsSponsorCentre Hospitalier Universitaire Grenoble Alpes

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