Accumulation of Nadroparin Used in Renal Insufficiency Assessed by anti-Xa levels
- Conditions
- venous thromboembolism10014523
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Age at least 18 years
- First day of high-prophylactic treatment with nadroparin
- GFR (based on Modification of Diet in Renal Disease (MDRD) calculation) 10-20 ml/min, 20-30 ml/min, 30-40 ml/min, 40-50 ml/min or 50 ml/min or higher (equal distribution of patients to be included over these 5 groups)
- High-prophylactic treatment dose of nadroparin of 5,700 anti-Xa activity IU once daily
- Subcutaneous nadroparin administration for at least 3 days
- Written informed consent
- Patients on an intensive care unit (ICU)
- Normal prophylactic dosages or therapeutic dosages of nadroparin for VTE
- GFR less than 10 ml/ml or dialysis
- Severe liver failure
- Pregnant patients or patients giving breast feeding
- Nadroparin in use for more than 2 days
- Adjustment of the dosage of nadroparin without measuring of anti-Xa level
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Anti-Xa levels will be measured 4 hours (± 1 hour) after subcutaneous injection<br /><br>of nadroparin on day 1 or day 2, day 3 and day 5 of treatment (if applicable<br /><br>day 10 of treatment as secondary endpoint). Primary outcome is the degree of<br /><br>accumulation, defined as the percentage of increase of anti-Xa level on day 5<br /><br>compared to day 1. This primary outcome will be assessed for various levels of<br /><br>renal function. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the percentage of increase of anti-Xa level on day 3<br /><br>compared to day 1, the percentage of increase of anti-Xa level on day 10<br /><br>compared to day 1, and bleeding complications during treatment with nadroparin<br /><br>(again this will be assessed for various levels of renal function).</p><br>