Accumulation of Nadroparin Used in Renal Insufficiency Assessed by anti-Xa levels.

• Conditions: nadroparin, accumulation, renal insufficiency, anti-Xa level, nadroparine, accumulatie, nierinsufficiëntie, anti-Xa spiegel

• Registration Number: NL-OMON26211
• Lead Sponsor: Erasmus MC Rotterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients are eligible to participate when they comply with the following inclusion criteria:

1. Age at least 18 years;

Exclusion Criteria

Patients are not eligible to participate with respect to the following exclusion criteria:

1. Patients on an intensive care unit (ICU);

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.