Prospective, multicentre, open-label study evaluating Fondaparinux (1,5 mg/day) in venous thromboembolic events prevention in patients with renal impairment defined by a creatinin clearance between 20 and 50 ml/min and undergoing a major orthopaedic surgery (hip fracture, total hip replacement and total knee replacement)

• Conditions: Patients with renal impairment defined by a creatinin clearance between 20 and 50 ml/min and undergoing a major orthopaedic surgery (hip fracture, total hip replacement and total knee replacement); MedDRA version: 9.1Level: LLTClassification code 10038474Term: Renal insufficiency; MedDRA version: 9.1Level: LLTClassification code 10020100Term: Hip fracture; MedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis; MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis; MedDRA version: 9.1Level: LLTClassification code 10020108Term: Hips osteoarthritis

• Registration Number: EUCTR2007-001048-32-FR
• Lead Sponsor: CHU SAINT-ETIENNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient affiliated with or a beneficiary of a social security category:
•age > 18 years old,
•requiring a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or resumption,
•requiring an antithrombotic prophylaxis,
•presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault’s formula,
•having signed the inform consent form.

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

•contra-indications to fondaparinux,
•history of heparin inducted thrombopenia (HIT),
•history of venous thromboembolic event,
•Haemorrhagic diathesis,
•PT < 50 %, aPTT > 1,5 of control value, platelets < 100 G/l.
incapacity to understand protocol

Study & Design

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