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

Completed

• Conditions: 10014523; Renal impairment; coagulation; 10038430

• Registration Number: NL-OMON44475
• Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• 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

- 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 invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The mean anti-Xa activity in patients with an eGFR < 60 ml/min and patients<br /><br>with an eGFR > 60 ml/min treated with therapeutic doses of nadroparin.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The mean anti-Xa activity in patients with an eGFR < 30 ml/min, 30-60 ml/min<br /><br>and > 60 ml/min.<br /><br>- The percentage of patients with an eGFR < 60 ml/min and > 60 ml/min,<br /><br>obtaining an adequate anti-Xa activity.<br /><br>- The percentage of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60<br /><br>ml/min, obtaining an adequate anti-Xa activity.<br /><br>- The number of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min<br /><br>experiencing a trombo-embolic event or bleeding complication during hospital<br /><br>admission.<br /><br>- The number of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min<br /><br>experiencing a trombo-embolic event during hospital admission.<br /><br>-The number of patients with an eGFR < 30 ml/min, 30-60 ml/min and > 60 ml/min<br /><br>experiencing a bleeding complication during hospital admission.</p><br>