title: Recombinant versus high-sensitivity conventional thromboplastin: a randomized clinical study in patients on oral anticoagulation.
abstract: A prospective, randomized, double-blind clinical trial was carried out in a single center to compare the clinical and laboratory quality of oral anticoagulant therapy monitored with recombinant tissue factor (RTF) or with a sensitive, human-derived, conventional thromboplastin (CT) in the PT test. Seven hundred and fifty-seven consecutive patients receiving oral anticoagulation for various indications were randomized to RTF (n = 379) or CT (n = 368) for 6 months. Total follow-up was 167 and 153 patient-years for RTF and TP groups respectively. Fifty-six bleeding events were observed: 31 in the RTF group and 25 in the TP group. The incidence of bleeding was 18.5 and 16.5% pt-yrs for RTF and TP patients respectively (n.s.). The event-free follow-up curves were not significantly different between the two groups. The laboratory quality of oral anticoagulation was evaluated with the "last check in file" method: therapeutic INR was found in the same proportion of RTF and TP patients (70.2% vs 68.8%). Our study shows that RTF is as effective as a sensitive, conventional thromboplastin for monitoring oral anticoagulation.
authors.affiliation: Department of Hematology, Ospedali Riuniti, Bergamo, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Finazzi
authors.forename: A
authors.initials: A
authors.lastname: Falanga
authors.forename: M
authors.initials: M
authors.lastname: Galli
authors.forename: S
authors.initials: S
authors.lastname: Cortelazzo
authors.forename: A
authors.initials: A
authors.lastname: Remuzzi
authors.forename: T
authors.initials: T
authors.lastname: Barbui
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D013925:Thromboplastin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D011994:Recombinant Proteins; D013925:Thromboplastin