Intermediate Versus Standard Dose Enoxaparin to Prevent Venous Thromboembolism in Severe Trauma Patients: a Multicenter Double Blind Randomised Controlled Trial
If you've had a serious injury, there's a risk of developing blood clots, also known as Venous Thromboembolism (VTE). These clots can be very dangerous. Hospitals usually give blood-thinning medicines like Enoxaparin to prevent them. However, sometimes these clots still occur, even with the standard dose. This study is looking at whether giving a slightly higher dose of Enoxaparin (called an 'intermediate dose') is more effective at preventing these dangerous blood clots in severely injured patients admitted to intensive care. We want to find out if this intermediate dose can reduce the number of clots without causing more problems like bleeding, compared to the standard dose.
At a glance
What is this study about?
When someone has a very serious injury, their body's healing process can sometimes lead to dangerous blood clots forming, particularly in the legs or lungs. These clots are called Venous Thromboembolism (VTE) and can be life-threatening. To prevent this, doctors often prescribe medicines that thin the blood, like Enoxaparin, which is a type of low-molecular-weight heparin.
Even with these preventive medicines, some severely injured patients still develop clots. This study aims to investigate if giving a slightly higher dose of Enoxaparin, referred to as an 'intermediate dose,' could be more effective at stopping these clots from forming compared to the usual 'standard dose.' Previous smaller studies have hinted that a higher dose might be better, but they weren't large enough or focused enough to give a clear answer.
The main goal of this research, called the HEPTRAUMA trial, is to see if doubling the standard dose of Enoxaparin can significantly reduce the number of serious blood clots in patients who have suffered severe trauma and are in intensive care. We also need to make sure that increasing the dose doesn't lead to more complications, especially bleeding.
Key takeaways
- Compares two Enoxaparin doses for clot prevention.
- Aims for safer, more effective clot prevention after severe injury.
- Participants will be in intensive care.
- Study is 'double blind' – dose unknown to patient/doctor.
- Potential for better clot prevention vs. risk of more bleeding.
Who may be eligible?
This study is looking for adults aged 18 or over who have had a serious injury and are admitted to an intensive care unit. You would need to be expected to stay in intensive care for more than two days and be planning to receive low-molecular-weight heparin, like Enoxaparin, to prevent blood clots. You would also need to be part of the French or European social security system.
There are several reasons why someone might not be able to join the study. For example, if you had a heart attack before coming to the hospital, or if more than three days have passed since your injury. You also couldn't take part if you've already received more than one dose of blood thinner since your injury.
Other reasons for not being able to join include having serious kidney problems, being very underweight (less than 7 stone) or very overweight (more than 15 stone 10 pounds), needing blood thinners for another medical condition, having certain blood clotting disorders, very low blood platelet counts, or a history of bad reactions to heparin. Severe bleeding, recent brain or spine surgery, pregnancy, breastfeeding, or being part of another experimental trial would also prevent participation.
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 or older?
- Have you had a recent serious injury requiring intensive care?
- Are you expected to stay in intensive care for more than 2 days?
- Do you have severe kidney problems or bleeding disorders?
- Are you pregnant or breastfeeding?
What does participation involve?
If you join this study, you would receive either the standard dose or an intermediate (slightly higher) dose of Enoxaparin, given as an injection, to prevent blood clots. It's a 'double blind' study, meaning neither you nor your doctors would know which dose you are receiving. Your medical team would closely monitor your health, looking for any signs of blood clots or bleeding. The total duration of your participation would depend on your hospital stay and recovery, but the blood thinning medicine would be given for as long as deemed necessary after your trauma.
Potential risks and benefits
Locations (17)
- CHU AngersVerified postcodeAngers, France
- CHU Clermont FerrandVerified postcodeClermont-Ferrand, France
- Hôpital Beaujon AP-HPVerified postcodeClichy, France
- CHU Grenoble AlpesVerified postcodeGrenoble, France
- AP-HP BicêtreVerified postcodeLe Kremlin-Bicêtre, France
- CHRU LilleVerified postcodeLille, France
- Hôpital Edouard Herriot HCLVerified postcodeLyon, France
- HCL Lyon SudVerified postcodeLyon, France
- Assistance Publique - Hôpitaux de MarseilleVerified postcodeMarseille, France
- CHU MontpellierVerified postcodeMontpellier, France
- CHU NantesVerified postcodeNantes, France
- Hôpital Pitié-Salpêtrière APHPVerified postcodeParis, France
Common questions
What are 'blood clots' and why are they dangerous?
Blood clots are clumps of blood that can form in your veins. If they get stuck, they can block blood flow and cause serious problems, especially if they travel to your lungs.
What is Enoxaparin?
Enoxaparin is a common medicine called a 'blood thinner' that helps prevent blood clots from forming, especially after surgery or serious injury.
What does 'double blind' mean?
It means neither you nor your doctors will know if you're getting the standard dose or the intermediate dose of the medicine. This helps ensure the study results are fair and unbiased.
Can I stop being part of the study once I've joined?
Yes, absolutely. You can withdraw from the study at any time, for any reason. Your decision will not affect your medical care.
Will this study definitely prevent me from getting a blood clot?
No study can guarantee prevention, but the aim of this research is to see if one dose is more effective than another at reducing the risk of blood clots.
How to find out more
Alexandre GODON
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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