Prophylaxis of venous thromboembolism in patients with a fracture of the lower extremity being treated conservatively with a below-knee plaster cast.

Phase 4

• Conditions: pulmonary embolism; thrombosis; 10014523

• Registration Number: NL-OMON39940
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 670

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The development of a deep-venous thombosis or pulmonary embolism.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety of nadroparin and fondaparinux.</p><br>