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Anti-Xa activity of nadroparin after a dose reduction (XANDO)


- candidate number21015
- NTR NumberNTR4974
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2014
- Secondary IDsXANDO NL50430.099.14
- Public TitleAnti-Xa activity of nadroparin after a dose reduction (XANDO)
- Scientific TitleAnti-Xa activity after a reduced therapeutic dose of nadroparin in patients with renal impairment using a dosage guideline of the Dutch Federation of Nephrology
- ACRONYMXANDO
- hypothesisLow-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
- Healt Condition(s) or Problem(s) studiedRenal insufficiency, Venous tromboembolism
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate1-jan-2017
- Target number of participants194
- InterventionsOne venous blood sample
- Primary outcomeThe 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- The mean anti-Xa activity in patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min. - The percentage of patients with an eGFR < 60 ml/min and > 60 ml/min, obtaining an adequate anti-Xa activity. - The percentage of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min, obtaining an adequate anti-Xa activity. - 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. - 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. -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.
- TimepointsA 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.
- Trial web siteNot applicable
- status[default]
- CONTACT FOR PUBLIC QUERIES A.L. van Ojik
- CONTACT for SCIENTIFIC QUERIES A.L. van Ojik
- Sponsor/Initiator Medisch Centrum Leeuwarden (MCL)
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Leeuwarden
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-nov-2014 - 17-mrt-2015


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