Lepirudin dose-dependently increases thrombelastography parameters at therapeutic plasma concentrations as measured with ROTEM(R) - a pilot study.

摘要

BACKGROUND: The aim of this in-vitro pilot study was to assess the usefulness of the thrombelastograph ROTEM(R) for determining the anticoagulant activity of lepirudin. METHODS: The ROTEM(R) parameters, clotting-time, clot formation time and maximum clot firmness were measured in the presence of increasing concentrations of lepirudin (10-4 mug/ml - 10 mug/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 1mug/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(R) device may be suitable for monitoring lepirudin at low concentrations but the results should be confirmed in a larger study and the ROTEM(R) device validated against standard methods.