COMPARISON BETWEEN RECOMBINANT AND RABBIT THROMBOPLASTIN IN THE MANAGEMENT OF PATIENTS ON ORAL ANTICOAGULANT-THERAPY

The aim of this study was to compare recombinant thromboplastin (rTF, ISI = 0.82) with rabbit thromboplastin (RT, ISI = 1.46) in order to ev aluate which performed better in our thrombosis centre. To this purpos e we randomized 67 patients to be double-blind monitored in two groups for three months either with PT performed with RT or with PT performe d with rTF. After this period each patient was shifted to the other gr oup. We considered the following as end points of the study: percentag es of PT results within the therapeutic range, number of visits and th erapeutic dose adjustments per patient. The ''last check in file'' met hod was used to evaluate the laboratory quality of oral anticoagulatio n for both thromboplastins. The results show that there was no differe nce in the number of visits per patient between the two groups: 6.9 +/ - 1.7 in the rTF group versus 7.3 +/- 1.9 in the RT group (p = 0.19). The variations of therapeutic dose per patient were not different in t he two groups: the dose was changed once (range 0-8) in the rTF group and once (range 0-11) in the RT group (p = 0.15). The percentages of P T results within the therapeutic range were not different between the two groups. The ''last check in file'' method showed similar percentag es in both groups: PT results in the therapeutic range were 67.2% in t he RT group and 68.8% in the rTF group. We conclude that the two throm boplastins had a similar effect on the end points of the study in spit e of the relatively high ISI of the RT.