?A Multicentre, Randomised, 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 Immobilisation for at least 21 Days and up to 45 Days because of Isolated Non-surgical Below-Knee Injury? - FONDAparinux in patients with a plaster CAST

• Conditions: on-surgical below-knee injury, immobilization with a plaster cast or brace, venous thromboembolism, bleeding events.; MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis

• Registration Number: EUCTR2008-004181-10-IT
• Lead Sponsor: GlaxoSmithKline R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-30
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

Male or female patients 18 years of age or older, Requiring rigid or semi-rigid immobilization (e.g. with a plaster cast or brace) for at least 21 days and up to 45 days, because of isolated non-surgical below-knee injury, With a no weight-bearing recommendation at the time of inclusion (partial weight bearing is permitted e.g. crutches, walking cast, relief shoes), Presenting at least one of the following risk factors for VTE: below-knee fracture or Achilles tendon rupture, age ≥40 years, body mass index > 30 kg/m2, oestrogen-containing hormonal replacement therapy or oral contraception, active cancer (treatment on going or stopped for less than one year) history of venous thomboembolism congenital or acquired hypercoagulable state Requiring thromboprophylaxis according to the Investigator`s judgement up to complete mobilization, corresponding to cast or brace removal. Able and willing to provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Delay between injury and randomization greater than two days, Treatment with antithrombotic or anticoagulant therapy, including low-dose anticoagulation, for more than 2 days prior to randomization, Anticoagulant therapy required or likely to be required during the study period for another reason (e.g. planned surgery justifying pharmacological thromboprophylaxis, curative dose for treatment of VTE, etc.) Known hypersensitivity to fondaparinux or nadroparin or their excipient, Known history of heparin-induced thrombocytopenia, Women of childbearing potential not using a reliable contraceptive method throughout the study period Women pregnant or breast-feeding during the study period. Exclusion criteria based on risk of bleeding associated with fondaparinux or other anticoagulant therapy: Active, clinically significant bleeding, Clinically significant bleeding within the past six months, Major surgery within the previous three months, Intraocular (other than cataract), spinal, and/or brain surgery within the previous twelve months, Haemorrhagic stroke within the previous twelve months, XM2008/00032/01 CONFIDENTIAL ART109350 31 CONFIDENTIAL XM2008/00032/01 ART109350 32 Severe head injury within the previous three months, Documented congenital or acquired bleeding tendency/disorder(s), Previous (within 12 months) or active or currently treated peptic ulcer disease, Uncontrolled arterial hypertension (systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg), Treatment with more than one antiplatelet agents (e.g. clopidogrel and aspirin) at any dose, Need for chronic aspirin at doses&#8805; 325 mg or chronic NSAIDs, Bacterial endocarditis, Severe hepatic impairment, Calculated creatinine clearance < 30 mL/min, Thrombocytopenia ( <100x109/L) Body weight < 50 kg. Other exclusion criteria related to trial methodology: Any condition that could prevent the patient from providing written informed consent or from adhering to study treatment, Life expectancy under six months, Participation in any study using an investigational drug during the previous three months, Patient in whom V3 is unlikely to be feasible (e.g. patient moving house)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified