Guidelines for the determination of haemorheological parameters and the performance of clinical therapeutic trials

Abstract

On evaluation of new haemorheological parameters strict criteria had to be applied. The normal range has to be determined by means of a sufficient number of suitable subjects. Sensibility, specificity and predictive value should be known. Internal and external quality controls must be performed in the daily laboratory routine.

The design of clinical trials with rheological active substances should be double-blind and placebo-controlled. The method of matched pairs is especially appropriate to achieve homogeneity in placebo and verum groups.