Intermediate versus standard dose enoxaparin to prevent venous thromboembolism in severe trauma patients: a multicenter double blind randomised controlled trial (HEPTRAUMA)

Conditions

Severe trauma

Brief summary

Composite of symptomatic deep vein thrombosis, proximal deep vein thrombosis, pulmonary embolism within 14 days following randomisation after severe trauma

Detailed description

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, 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

Related papers

No related papers found yet.

Interventions

DRUGLOVENOX 30 000 UI (300 mg)/3 ml

DRUGsolution injectable

DRUGPLACEBO _ HEPTRAUMA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Composite of symptomatic deep vein thrombosis, proximal deep vein thrombosis, pulmonary embolism within 14 days following randomisation after severe trauma	—

Secondary

Measure	Time frame
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, 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	—

Measure

Time frame

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, 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

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Countries

France

Outcome results

None listed