Anti-Xa activity after a reduced therapeutic dose of nadroparin in patients with renal impairment using a dosage guideline of the Dutch Federation of Nephrology

Anti-Xa activity after a reduced therapeutic dose of nadroparin in patients with renal impairment using a dosage guideline of the Dutch Federation of Nephrology - Anti-Xa activity of nadroparin after a dose reduction (XANDO)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44475

Enrollment

194

Registered

2014-12-18

Start date

2015-01-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation Renal impairment

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
The mean anti-Xa activity in patients with an eGFR 60 ml/min treated with therapeutic doses of nadroparin.	—

Secondary

Measure	Time frame
- The mean anti-Xa activity in patients with an eGFR 60 ml/min. - The percentage of patients with an eGFR 60 ml/min, obtaining an adequate anti-Xa activity. - The percentage of patients with an eGFR 60 ml/min, obtaining an adequate anti-Xa activity. - The number of patients with an eGFR 60 ml/min experiencing a trombo-embolic event or bleeding complication during hospital admission. - The number of patients with an eGFR 60 ml/min experiencing a trombo-embolic event during hospital admission. -The number of patients with an eGFR 60 ml/min experiencing a bleeding complication during hospital admission.	—

Measure

Time frame

- The mean anti-Xa activity in patients with an eGFR 60 ml/min. - The percentage of patients with an eGFR 60 ml/min, obtaining an adequate anti-Xa activity. - The percentage of patients with an eGFR 60 ml/min, obtaining an adequate anti-Xa activity. - The number of patients with an eGFR 60 ml/min experiencing a trombo-embolic event or bleeding complication during hospital admission. - The number of patients with an eGFR 60 ml/min experiencing a trombo-embolic event during hospital admission. -The number of patients with an eGFR 60 ml/min experiencing a bleeding complication during hospital admission.

—

Countries

Netherlands

Outcome results