Intermediate Versus Standard Dose Enoxaparin to Prevent Venous Thromboembolism in Severe Trauma Patients: a Multicenter Double Blind Randomised Controlled Trial

Sponsor
University Hospital, Grenoble
Study ID
NCT07506473
Status
Not Yet Recruiting

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Conditions

  • Severe Trauma Patient
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enoxaparin standard dose — DRUG
    In the control group, patients will receive 1 injection of enoxaparin 4000 IU and 1 injection of placebo until day 14 or hospital discharge in the same form as enoxaparin (subcutaneous injection). A placebo injection is administered as needed to maintain blinding and ensure the same number of injections as in the intermediate-dose arm.
  • Enoxaparin intermediate dose — DRUG
    In the experimental group, patients will receive 2 injections of enoxaparin 4000 IU until day 14 or hospital discharge.

Study Details

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). 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.

Key Dates

First listed
Apr 1, 2026
Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Standard Dose LMWH
    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.
  • Experimental: Intermediate Dose LMWH
    Patients in the experimental group receive a intermediate dose of enoxparin. They receive two injections of enoxaparin per day.

Primary Outcome Measure

Composite of symptomatic deep vein thrombosis (DVT), proximal DVT, pulmonary embolism (PE). [ Time Frame: Within 14 days following randomisation after severe trauma ]

Central Contacts

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