Anti-Xa activity of nadroparin after a dose reduction (XANDO)
- Conditions
- Renal impairmentVenous thromboembolism NierinsufficiëntieVeneuze trombo-embolie
- Registration Number
- NL-OMON23816
- Lead Sponsor
- Medisch Centrum Leeuwarden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 194
Inclusion Criteria
Age at least 18 years
- Therapeutic dose of Fraxiparine or Fraxodi
- Subcutaneous nadroparin administration for at least three days
- Written informed consent
Exclusion Criteria
- Use of nadroparin before hospital admission
- Patients known for heparin resistance
- Patients on hemodialysis
- Use of antifactor Xa inhibitors other than nadroparin (all remaining LMWHs, dabigatran, apixaban, rivaroxaban, heparin and fondaparinux) within 7 days before the start of the study or during the study
- Use of Cofact or Beriplex within 7 days before the start or during the study
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean anti-Xa activity in patients with an eGFR < 60 ml/min and patients with an eGFR > 60 ml/min treated with therapeutic doses of nadroparin.
- Secondary Outcome Measures
Name Time Method - The mean anti-Xa activity in patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min. <br>- The percentage of patients with an eGFR < 60 ml/min and > 60 ml/min, obtaining an adequate anti-Xa activity. <br>- The percentage of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min, obtaining an adequate anti-Xa activity. <br>- The number of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min experiencing a trombo-embolic event or bleeding complication during hospital admission. <br>- The number of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min experiencing a trombo-embolic event during hospital admission.<br>-The number of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min experiencing a bleeding complication during hospital admission.