The influence of renal function on the amount of nadroparin in blood

• Conditions: Venous thromboembolism; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-002128-41-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-08
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

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

Inclusion Criteria

- 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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