EFFICIENCY AND TOLERANCE OF FRAXIPARINE(R ) (CY-216) FOR THE PREVENTION OF POSTOPERATIVE DEEP-VEIN THROMBOSIS IN PATIENTS UNDERGOING GENERAL-SURGERY UNDER EPIDURAL-ANESTHESIA

From 1989 to 1991, 480 patients undergoing general surgery under epidu ral anaesthesia were included in a multicentre, comparative, randomize d, open-study designed to assess whether calcium nadroparin (Fraxipari ne(R)), one daily subcutaneous injection of 0.3 mL, i.e. 3 075 anti Xa IU per day, is more efficiency and better tolerated than a non-fragme nted standard heparin (Calciparine(R)), one subcutaneous injection of 0.2 mL t.i.d. 15 000 IU per day, for the prevention of postoperative d eep vein thrombosis (DVT). The 480 patients, treated in 78 centres, we re randomized in two groups (Fraxiparine(R), n = 241 ; Calciparine(R), n = 239). In both groups, treatment was started two hours after the e nd of the surgical procedure. Hernia repair and prostatic surgery acco unted for 60 % of operations. Thromboembolic events were detected by c linical examination performed at regular time intervals and by a syste matic exam (doppler and rheoplethysmography or ultrasonogram) at the e nd of the treatment. Both agents demonstrated a similar efficiency. Th ere was only one case of DVT, confirmed by phlebography in the Fraxipa rine(R) group. Tolerance was good in both groups. The proportion of pa tients requiring a transfusion was low (3 % in each group). Hematuria was relatively frequent (33 % in the Fraxiparine(R) group and 28 % in the Calciparine(R) group), however these rates were related to prostat ic and urinary incontinence surgery. This study, including a wide seri es of patients undergoing general surgery under epidural anaesthesia, demonstrates that efficiency and tolerance of one daily injection of F raxiparine(R) are similar to those of three daily injections of Calcip arine(R). It it concluded that Fraxiparine(R) improves of the patient' s comfort and decreases the nursing work load.