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FONDAparinux in patients with a plaster CAST (FONDACAST): A Multicentre, Randomized, Open-label, Controlled, Two-Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Fondaparinux ve...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-004181-10

FONDAparinux in patients with a plaster CAST (FONDACAST): A Multicentre, Randomized, Open-label, Controlled, Two-Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Fondaparinux versus Low-molecular-Weight Heparin (Nadroparin), in Patients Requiring Rigid or Semi-rigid Immobilization for at least 21 Days and up to 45 Days because of Isolated Non-surgical Below-Knee Injury

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Extrait

The primary objective of the study is to demonstrate the superiority of fondaparinux 2.5 mg (1.5 mg in patients with a creatinine clearance between 30 and 50 mL/min) once daily versus LMWH (nadroparin 2850 anti-Xa IU (0.3 mL) once daily), with respect to the occurrence of VTE or death up to complete mobilization, corresponding to cast or brace removal, in patients requiring rigid or semi-rigid immobilization for at least 21 days and up to 45 days for an isolated non-surgical isolated below-knee injury.

Critère d'inclusion

  • Isolated non-surgical below-knee injury (e.g. broken leg or achilles rupture with no weight bearing recommendation)

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