pulmonary embolism thrombosis
Conditions
Interventions
one group will receive 0,3 ml nadroparin s.c. once daily
one group will receive 0,5 ml fondaparinux s.c. once daily
one group recieves no intervention
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study groups and the control group will consist of patients of 18 years or older with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks.
Exclusion criteria
Exclusion criteria: Delay between injury and randomisation greater than three days • Pregnancy/lactation • Severe hepatic impairment • Known hypersensitivity to fraxiparine or fondaparinux • History of venous thromboembolism • Documented congenital or acquired bleeding tendency/disorder(s) • Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis • Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) • Haemorrhagic stroke within the previous two months • Intraocular, spinal, and/or brain surgery within the previous twelve months • Major surgery within the previous two months • Treatment with LMWH or other anticoagulants • Inability or refusal to give informed consent • Inability to comply with the study-instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development of a deep-venous thombosis or pulmonary embolism. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of nadroparin and fondaparinux. | — |
Countries
Netherlands
Outcome results
None listed