Status:
COMPLETED
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Lead Sponsor:
Luzerner Kantonsspital
Collaborating Sponsors:
Pfizer
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18+ years
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00264693
Start Date
January 1 2006
End Date
May 1 2008
Last Update
January 26 2010
Active Locations (1)
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1
Kantonsspital Luzern
Lucerne, Canton of Lucerne, Switzerland, 6000