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Intermediate versus standard dose enoxaparin to prevent venous thromboembolism in severe trauma patients: a multicenter double blind randomised controlled trial (HEPTRAUMA)
EU CTIS ID: 2025-522832-16-00
What this study is testing
To determine the effect of intermediate versus standard dose low-molecular-weight heparin on the incidence of major venous thromboembolism following severe trauma.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All adult patients (age ≥18 years) admitted to an intensive care unit following trauma with an expected stay >48 hours and a planned administration of LMWH
- Affiliation to the French social security system or European (CEAM)
You likely can't join if
- Prehospital cardiac arrest
- History of heparin-induced thrombocytopenia
- Study drug hypersensitivity
- Limitation of life support, life expectancy ≤7 days or palliative care
- Contraindication to the administration of anticoagulant according to the SPC (Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent haemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmological surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intrarachid or intracerebral vascular anomalies.)
- Pregnant or breastfeeding woman
See the full eligibility criteria
- All adult patients (age ≥18 years) admitted to an intensive care unit following trauma with an expected stay >48 hours and a planned administration of LMWH
- Affiliation to the French social security system or European (CEAM)
- Prehospital cardiac arrest
- History of heparin-induced thrombocytopenia
- Study drug hypersensitivity
- Limitation of life support, life expectancy ≤7 days or palliative care
- Contraindication to the administration of anticoagulant according to the SPC (Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent haemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmological surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intrarachid or intracerebral vascular anomalies.)
- Pregnant or breastfeeding woman
- Inclusion in another experimental trial
- Protected person (art. L1121-5 to L1121-8 of the CSP or art. 31 to 35 of European regulation 536/2014)
- Hospital admission >72 hours
- More than one dose of prophylactic anticoagulant already administered since trauma
- Renal failure defined by creatinine clearance of 30 mL/min or less (Cockcroft-Gault formula)
- Body weight >100 kg or <45 kg
- Indication for therapeutic anticoagulation
- Major known thrombophilia (e.g. antiphospholipid syndrome, antithrombin deficiency)
- Constitutional bleeding disorder (haemophilia, von Willebrand disease, coagulation factor deficiency, platelet disorder).
- Thrombocytopenia inferior to 50 G.L-1
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.