Low-molecular-weight heparins (LMWHs) are frequently used in the prophylaxis and therapy of venous thromboembolism (VTE) and the prophylaxis of arterial thromboembolism. LMWHs are mainly excreted by the kidneys and may accumulate in patients with…
ID
Bron
Verkorte titel
Aandoening
Renal impairment
Venous thromboembolism
Nierinsufficiëntie
Veneuze trombo-embolie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Doel van het onderzoek
Low-molecular-weight heparins (LMWHs) are frequently used in the prophylaxis and therapy of venous thromboembolism (VTE) and the prophylaxis of arterial thromboembolism. LMWHs are mainly excreted by the kidneys and may accumulate in patients with renal impairment, leading to an increased anti-Xa activity which is associated with an increased risk of bleeding complications. Current dosage guidelines of the Dutch Federation of Nephrology (NfN) and the Royal Dutch Pharmacists Association (KNMP) recommend a dose reduction in patients with renal impairment, followed by determination of the anti-Xa activity in patients treated for more than three days. The evidence supporting this recommendation is sparse. To date, no data is available about the effect of nadroparin in obtaining an adequate anti-Xa activity in patients with renal impairment (eGFR < 60 ml/min) after dose reduction, but also not in patients with a normal renal function (eGFR > 60 ml/min) treated with a standard therapeutic dose of nadroparin. In this study, we therefore determine the anti-Xa activity after a reduced therapeutic dose of nadroparin in patients with an eGFR < 60 ml/min in comparison with the anti-Xa activity after a standard therapeutic dose of nadroparin in patients with an eGFR > 60 m/min, using the dosage guideline of the Dutch Federation of Nephrology
Onderzoeksopzet
A blood sample will be drawn by venipuncture 4 hours after the 6th administration of Fraxiparine or the 3rd administration of Fraxodi. Though, blood samples collected 4 hours after the 7th respectively 4th administration are also accepted.
Onderzoeksproduct en/of interventie
One venous blood sample
Publiek
A.L. van Ojik
Leeuwarden 8901 BR
The Netherlands
+31 58 286 1251
Annette.van.Ojik@znb.nl
Wetenschappelijk
A.L. van Ojik
Leeuwarden 8901 BR
The Netherlands
+31 58 286 1251
Annette.van.Ojik@znb.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age at least 18 years
- Therapeutic dose of Fraxiparine or Fraxodi
- Subcutaneous nadroparin administration for at least three days
- Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL4704 |
NTR-old | NTR4974 |
Ander register | NL50430.099.14 : XANDO |