ENOXAPARIN SODIUM for Severe trauma

Inclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Affiliation to the French social security system or European (CEAM)"}

Exclusion criteria

• {"criterion_text":"- Prehospital cardiac arrest"}
• {"criterion_text":"- History of heparin-induced thrombocytopenia"}
• {"criterion_text":"- Study drug hypersensitivity"}
• {"criterion_text":"- Limitation of life support, life expectancy ≤7 days or palliative care"}
• {"criterion_text":"- 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.)"}
• {"criterion_text":"- Pregnant or breastfeeding woman"}
• {"criterion_text":"- Inclusion in another experimental trial"}
• {"criterion_text":"- Protected person (art. L1121-5 to L1121-8 of the CSP or art. 31 to 35 of European regulation 536/2014)"}
• {"criterion_text":"- Hospital admission >72 hours"}
• {"criterion_text":"- More than one dose of prophylactic anticoagulant already administered since trauma"}
• {"criterion_text":"- Renal failure defined by creatinine clearance of 30 mL/min or less (Cockcroft-Gault formula)"}
• {"criterion_text":"- Body weight >100 kg or <45 kg"}
• {"criterion_text":"- Indication for therapeutic anticoagulation"}
• {"criterion_text":"- Major known thrombophilia (e.g. antiphospholipid syndrome, antithrombin deficiency)"}
• {"criterion_text":"- Constitutional bleeding disorder (haemophilia, von Willebrand disease, coagulation factor deficiency, platelet disorder)."}
• {"criterion_text":"- Thrombocytopenia inferior to 50 G.L-1"}

Primary endpoints

• {"endpoint_text":"- Composite of symptomatic deep vein thrombosis, proximal deep vein thrombosis, pulmonary embolism within 14 days following randomisation after severe trauma","definition_or_measurement_approach":"Occurrence of symptomatic deep vein thrombosis (including proximal DVT) or pulmonary embolism within 14 days following randomisation after severe trauma (composite outcome measured within 14 days post-randomisation)."}

Secondary endpoints

• {"endpoint_text":"- Key secondary endpoint (included in a sequential hierarchical testing procedure): Composite of major venous thromboembolism, as defined in the primary endpoint, and major bleedings, defined by (i) the need for a haemostatic invasive procedure because of bleeding, (ii) the need for interruption of prophylactic enoxaparin for ≥48 hours because of bleeding, or (iii) bleeding in a critical organ within 14 days following randomisation after a severe trauma","definition_or_measurement_approach":"Composite of major VTE (as per primary endpoint) combined with major bleeding defined as: (i) need for haemostatic invasive procedure due to bleeding, (ii) interruption of prophylactic enoxaparin for ≥48 hours because of bleeding, or (iii) bleeding in a critical organ within 14 days following randomisation."}
• {"endpoint_text":"- Other endpoints: Major or clinically relevant non-major bleeding, as per ISTH definition, occurring during or within 48h of the last dose of study drug; Incidence of major venous thromboembolism (as defined in the primary endpoint) and major bleeding (as per ISTH definition) at day 30 following randomisation; death at day 30 following randomisation","definition_or_measurement_approach":"Major or clinically relevant non-major bleeding defined by ISTH, occurring during treatment or within 48 hours of the last dose; incidence of major VTE and major bleeding at day 30 post-randomisation; death at day 30 post-randomisation."}

Other endpoints

• {"endpoint_text":"- Major or clinically relevant non-major bleeding, as per ISTH definition, occurring during or within 48h of the last dose of study drug","definition_or_measurement_approach":"Bleeding classified according to ISTH definition, time window: during treatment or within 48 hours of last dose."}
• {"endpoint_text":"- Incidence of major venous thromboembolism (as defined in the primary endpoint) and major bleeding (as per ISTH definition) at day 30 following randomisation","definition_or_measurement_approach":"Occurrence of major VTE and major bleeding at day 30 following randomisation; definitions as per primary endpoint and ISTH."}
• {"endpoint_text":"- death at day 30 following randomisation","definition_or_measurement_approach":"All-cause death assessed at day 30 following randomisation."}

France

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

23

Number Of Sites

14

Number Of Participants

540

Primary sponsor

Full Name

Centre Hospitalier Universitaire Grenoble Alpes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France