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Higher versus usual enoxaparin dose to prevent blood clots after severe injury

Tests a higher enoxaparin dose against venous thromboembolism after severe trauma.

Key facts

Who runs it
University Hospital, Grenoble
Where
France17 sites in 1 countryChoose a country to see its sites
Registry title
Intermediate Versus Standard Dose Enoxaparin to Prevent Venous Thromboembolism in Severe Trauma Patients: a Multicenter Double Blind Randomised Controlled Trial
Status
Not yet recruiting
People taking part
540 people, planned
Started
Apr 2026
Expected to end
May 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Enoxaparin standard dose
  • Enoxaparin intermediate dose
Record updated
29 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe injuries who are in intensive care. They must be expected to stay more than 48 hours and be planned to get LMWH, a blood thinner given to prevent blood clots.

Age
18 years and older
Sex
All sexes
Disease stage
Severe trauma (injury) needing an intensive care stay expected to last more than 48 hours. Admission to hospital no more than 72 hours ago.
Earlier treatment
Not more than one dose of blood thinner to prevent clots since the injury. People who need full-dose blood thinner treatment cannot join.
Biomarker or test result
Creatinine clearance (a kidney test) must be above 30 mL/min. Platelet count must not be below 50 G.L-1. Body weight 45 kg (99 lb) to 100 kg (220 lb).

Main reasons for not taking part

  • Heart stopped before reaching hospital
  • Active serious bleeding or a high risk of bleeding
  • Bleeding disorder or major known clotting disorder, or past heparin-induced low platelets
  • Life expectancy of 7 days or less, limited life support or palliative care
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Prehospital cardiac arrest
  • Major known thrombophilia (e.g. antiphospholipid syndrome, antithrombin deficiency)
  • History of heparin-induced thrombocytopenia
  • Study drug hypersensitivity
  • 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.)
  • Renal failure defined by creatinine clearance of 30 mL/min or less (Cockcroft-Gault formula)
  • Constitutional bleeding disorder (haemophilia, von Willebrand disease, coagulation factor deficiency, platelet disorder)
  • Hospital admission >72 hours
  • More than one dose of prophylactic anticoagulant already administered since trauma
  • Body weight >100 kg or <45 kg
  • Indication for therapeutic anticoagulation
  • Thrombocytopenia inferior to 50 G.L-1
  • Limitation of life support, life expectancy ≤7 days or palliative care
  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Venous thromboembolism is a frequent issue in severe trauma patients. Guidelines for venous thromboembolism prevention include the use of pharmacological thromboprophylaxis, mainly with low-molecular-weight heparin, and/or mechanical thromboprophylaxis. However, a high incidence of venous thromboembolism is observed despite standard dose thromboprophylaxis (such as enoxaparin 40 mg once daily).

Read full original descriptionShow less

An increase of the dose of anticoagulants could improve thromboprophylaxis in trauma patients. To date, two randomised trials have assessed the effect of weight-based low-molecular-weight heparin dosing vs. fixed dose in trauma patients. These pilot studies did not demonstrate a statistical difference between groups although there was a trend in favour of a lower incidence of deep vein thromboses with the increased dose low-molecular-weight heparin prophylaxis. However, both studies included non-severe trauma patients and the second study focused only on deep vein thromboses. Other studies suggested that a superior-than-standard dose of low-molecular-weight heparin, sometimes

guided by the anti-Xa activity, decreases the incidence of venous thromboembolism in severe trauma without increasing bleeding events, but they were observational in nature.

The hypothesis of the HEPTRAUMA trial is that, in severe trauma patients, a thromboprophylaxis with intermediate dose low-molecular-weight heparin (twice the standard dose) decreases the incidence of major venous thromboembolism compared to standard dose.

The 2 groups in the trial

  • Standard Dose LMWHExisting treatment, for comparison

    Patients in the control group receive a standard dose of enoxaparin during 14 days. They will receive two injections per day, one of them being a placebo.

    Treatment: Enoxaparin standard dose

  • Intermediate Dose LMWHTreatment being tested

    Patients in the experimental group receive a intermediate dose of enoxparin. They receive two injections of enoxaparin per day.

    Treatment: Enoxaparin intermediate dose

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Intermediate Versus Standard Dose Enoxaparin to Prevent Venous Thromboembolism in Severe Trauma Patients: a Multicenter Double Blind Randomised Controlled Trial
Plain-language title
Higher versus usual enoxaparin dose to prevent blood clots after severe injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
29 April 2026