Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Information source: Luzerner Kantonsspital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Insufficiency
Phase: Phase 4
Status: Completed
Sponsored by: Luzerner Kantonsspital Official(s) and/or principal investigator(s):
Pirmin Schmid, MD, Principal Investigator, Affiliation: Luzerner Kantonsspital, Hematology
Andreas G Fischer, MD, Study Director, Affiliation: Luzerner Kantonsspital, Nephrology
Walter A Wuillemin, MD, PhD, Study Chair, Affiliation: Luzerner Kantonsspital, Hematology
Summary
Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as
unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and
in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of
oral anticoagulation with vitamin K antagonists (VKA).
Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with
impaired renal function. Official guidelines recommend therefore to use LMWH controlled by
Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation
therapy in patients with severe renal insufficiency.
Although dosage recommendations have been proposed for enoxaparin in patients with renal
impairment based on several studies, these data cannot be applied to other LMWH directly due
to different pharmacokinetic properties of each drug.
The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal
insufficiency, especially addressing the question of accumulation after multiple doses and
including patients with severe renal insufficiency and derive a safe and suitable concept
for using dalteparin in patients with impaired renal function.
Clinical Details
Official title: Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Study design: Observational Model: Cohort, Time Perspective: Prospective
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient starting with dalteparin for prophylaxis OR therapy by order of the treating
physician (after having evaluated clinical indication and contraindications).
- Renal function normal OR impaired with or without dialysis therapy according to open
study groups
- Age >= 18 years
- Written informed consent
Exclusion Criteria:
- Pregnancy / Lactation
- Dalteparin or other LMWH already in use for > 1 day, unless just in use during
hemodialysis
- Anti-Xa level before first application of dalteparin > 0. 3 U / ml
- Participation in another study
- Anuria OR glomerular filtration rate < 10 ml/min without dialysis
- Patient on intensive care unit (ICU)
- Cardiovascular unstable patient or probable need for a quick stop of anticoagulation
(e. g. emergency surgery)
- Patient with a disease whose estimated life expectancy is < 28 days
Locations and Contacts
Kantonsspital Luzern, Luzern, LU 6000, Switzerland
Additional Information
Luzerner Kantonsspital, Hematology Luzerner Kantonsspital, Nephrology Pirmin Schmid
Related publications: Schmid P, Fischer AG, Wuillemin WA. Low-molecular-weight heparin in patients with renal insufficiency. Swiss Med Wkly. 2009 Aug 8;139(31-32):438-52. doi: smw-11284. Review.
Starting date: January 2006
Last updated: January 25, 2010
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