The primary objective of this study is to 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…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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.
Background summary
Low-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
Study objective
The primary objective of this study is to 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.
Study design
Prospective observational cohort study
Study burden and risks
Potential risk:
The drawing of one blood sample is a procedure through which subjects can
experience discomfort. Because of a different sampling time, this can not be
combined with the drawing of routine laboratory blood samples. Though, patients
admitted to general medical or surgical wards of Medisch Centrum Leeuwarden or
the Isala in Zwolle are frequently subjected to this procedure. For this reason
the risks associated with participation can be considered negligible and the
burden can be considered minimal.
Potential benefit:
In Medisch Centrum Leeuwarden and the Isala in Zwolle, patients are treated
with LMWH nadroparin according to the Summary of Product Characteristics (SPC)
and dosage guideline of the NfN. Still to date, measuring anti-Xa activity is
not advised as standard care in Medisch Centrum Leeuwarden since the Clinical
Chemistry Laboratory is not capable to determine anti-Xa activity routinely. In
the Isala in Zwolle measuring anti-Xa activity is also not advised as standard
care.
LMHWs 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 a 2- to 3-fold increased risk of bleeding complications. No studies are
available describing the effect of nadroparin in obtaining adequate anti-Xa
activity in patients with an eGFR < 60 ml/min after dose reduction according to
the dosage guideline of the NfN, but also not in patients with an eGFR > 60
ml/min treated with a standard therapeutic dose of nadroparin. An adequate
anti-Xa activity is required because underdosing is associated with an
increased risk of thrombo-embolic events, while overdosing is associated with
an increased risk of bleeding complications. Findings of this study will be
helpful to confirm the accuracy of the used dosage guideline of the NfN and can
influence future dosing schedules in patients with renal impairment treated
with nadroparin.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
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
Design
Recruitment
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 |
|---|---|
| CCMO | NL50430.099.14 |