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