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 evaluate which performed better in our thrombosis centre. To this purpose we randomized 67 patients to be double-blind monitored in two groups for three months either with PT performed with RT or with PT performed with rTF. After this period each patient was shifted to the other group. We considered the following as end points of the study: percentages of PT results within the therapeutic range, number of visits and therapeutic dose adjustments per patient. The "last check in file" method was used to evaluate the laboratory quality of oral anticoagulation for both thromboplastins. The results show that there was no difference 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 the 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 PT results within the therapeutic range were not different between the two groups. The "last check in file" method showed similar percentages in both groups: PT results in the therapeutic range were 67.2% in the RT group and 68.8% in the rTF group. We conclude that the two thromboplastins had a similar effect on the end points of the study in spite of the relatively high ISI of the RT.
Barcellona
D
D
Istituto di Medicina Intema, University of Cagliari, Italy.
Biondi
G
G
Vannini
M L
ML
Marongiu
V F
VF
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000818:Animals; D000925:Anticoagulants / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011817:Rabbits; D011994:Recombinant Proteins / Q000627:therapeutic use; D013925:Thromboplastin / Q000627:therapeutic use*
D000925:Anticoagulants; D011994:Recombinant Proteins; D013925:Thromboplastin