EUCTR2007-001048-32-FR
Active, not recruiting
Not Applicable
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)
CHU SAINT-ETIENNE0 sitesMarch 29, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU SAINT-ETIENNE
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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