Lepirudin dose-dependently increases thrombelastography parameters at therapeutic plasma concentrations as measured with ROTEM® - a pilot study

Int J Clin Pharmacol Ther. 2011 Oct;49(10):626-8. doi: 10.5414/cp201542.

Abstract

Background: The aim of this in-vitro pilot study was to assess the usefulness of the thrombelastograph ROTEM® for determining the anticoagulant activity of lepirudin.

Methods: The ROTEM® parameters, clotting-time, clot formation time and maximum clot firmness were measured in the presence of increasing concentrations of lepirudin (10-4 μg/ml - 10 μg/ml). Citrated blood was obtained from 16 healthy male subjects.

Results: Clotting-time increased from 79.1 ± 53.4 s at baseline to 194.1 ± 151.9 s at a drug concentration of 1μg/ml as measured with EXTEM (p < 0.0001). Borderline significance was found for the difference between maximum clot firmness at baseline (60.2 ± 4.3 mm) and after drug application (55.5 ± 6.5 mm).

Conclusions: This pilot investigation shows that the ROTEM® device may be suitable for monitoring lepirudin at low concentrations but the results should be confirmed in a larger study and the ROTEM® device validated against standard methods.

MeSH terms

  • Adult
  • Anticoagulants / blood
  • Anticoagulants / pharmacology*
  • Dose-Response Relationship, Drug
  • Hirudins / blood
  • Hirudins / pharmacology*
  • Humans
  • Male
  • Pilot Projects
  • Recombinant Proteins / blood
  • Recombinant Proteins / pharmacology
  • Thrombelastography*
  • Whole Blood Coagulation Time

Substances

  • Anticoagulants
  • Hirudins
  • Recombinant Proteins
  • lepirudin