The aim of this study is to determine the accumulation of nadroparin used in renal insufficient patients with VTE, by measuring anti-Xa levels.
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anti-Xa levels will be measured 4 hours (± 1 hour) after subcutaneous injection
of nadroparin on day 1 or day 2, day 3 and day 5 of treatment (if applicable
day 10 of treatment as secondary endpoint). 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
Secondary endpoints are the percentage of increase of anti-Xa level on day 3
compared to day 1, the percentage of increase of anti-Xa level on day 10
compared to day 1, and bleeding complications during treatment with nadroparin
(again this will be assessed for various levels of renal function).
Background summary
Prevention of venous thromboembolism (VTE) with low-molecular-weight heparins
(LMWHs) is confirmed to be more effective compared to unfractionated heparin
(UFH). In comparison to UFH, the LMWHs have improved pharmacokinetics, ease of
administration and lack of need of laboratory monitoring, which has greatly
increased the use of LMWHs. Because the elimination of LMWHs is mainly
determined by renal excretion, the use of LMWHs in patients with renal
insufficiency might lead to accumulation of the drug, accompanied by an
increase in anti-Xa level and thereby a greater risk for hemorrhagic
complications.
For the normal prophylactic dose of nadroparin, there are no studies available
suggesting dose adjustment in patients with renal insufficiency. Because of
this, in our hospital, we do not adjust the normal prophylactic dose of
nadroparin. For the high prophylactic dose of nadroparin currently no
information is available on possible accumulation in patients with renal
insufficiency. Because of the clear risk of accumulation in therapeutic dose,
one might assume that a high prophylactic dose may accumulate as well, but
evidence is lacking.
Therefore, this study aims to investigate the possible accumulation of
nadroparin in high prophylactic dosages in patients with renal insufficiency.
Study objective
The aim of this study is to determine the accumulation of nadroparin used in
renal insufficient patients with VTE, by measuring anti-Xa levels.
Study design
Prospective, observational, follow-up study.
Study burden and risks
The patient will be asked for 4 blood samples of 4.5 ml to measure the anti-Xa
level during treatment with nadroparin. Standard care will be provided, so if
the doctor does not decide to measure anti-Xa himself, then the anti-Xa
analyses will take place in batches after day 10 of treatment with nadroparin
(and thus the values will not be used to adjust therapy during the study
period). If still relevant (i.e. when nadroparin is still in use) the anti-Xa
levels will be communicated to the doctor after day 10.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Age at least 18 years
- First day of high-prophylactic treatment with nadroparin
- GFR (based on Modification of Diet in Renal Disease (MDRD) calculation) 10-20 ml/min, 20-30 ml/min, 30-40 ml/min, 40-50 ml/min or 50 ml/min or higher (equal distribution of patients to be included over these 5 groups)
- High-prophylactic treatment dose of nadroparin of 5,700 anti-Xa activity IU once daily
- Subcutaneous nadroparin administration for at least 3 days
- Written informed consent
Exclusion criteria
- Patients on an intensive care unit (ICU)
- Normal prophylactic dosages or therapeutic dosages of nadroparin for VTE
- GFR less than 10 ml/ml or dialysis
- Severe liver failure
- Pregnant patients or patients giving breast feeding
- Nadroparin in use for more than 2 days
- Adjustment of the dosage of nadroparin without measuring of anti-Xa level
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002128-41-NL |
| CCMO | NL36591.078.11 |