nadroparin, accumulation, renal insufficiency, anti-Xa level, nadroparine, accumulatie, nierinsufficiëntie, anti-Xa spiegel
Conditions
Interventions
No interventions will be done, as this is an observational study.
Sponsors
Erasmus MC Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: Patients are eligible to participate when they comply with the following inclusion criteria: 1. Age at least 18 years; 2. Diagnosed with VTE; 3. First day of therapy with nadroparin; 4. 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); 5. Treatment dose of nadroparin of at least 7,600 anti-Xa activity IU once daily or 5,700 anti-Xa activity IU twice daily; 6. Subcutaneous nadroparin administration for at least 3 days; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: Patients are not eligible to participate with respect to the following exclusion criteria: 1. Patients on an intensive care unit (ICU); 2. Prophylactic dosages of nadroparin for VTE; 3. GFR less than 10 ml/ml or dialysis; 4. Severe liver failure; 5. Pregnant patients or patients giving breast feeding; 6. Nadroparin in use for more than 1 day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-Xa levels will be measured 4 hours (± 1 hour) after subcutaneous injection of nadroparin on day 1, day 3 and day 5 of treatment. Primary outcome is the degree of accumulation, defined as the percentage of increase of anti-Xa level on day 5 compared to day 1. This primary outcome will be assessed for various levels of renal function. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the percentage of increase of anti-Xa level on day 3 compared to day 1 and bleeding complications during treatment with nadroparin. | — |
Contacts
Public ContactR.R. Boedhram
Erasmus MC - afdeling Apotheek 's Gravendijkwal 230
Outcome results
None listed