[Efficacy and tolerance of Fraxiparine in the prevention of deep vein thrombosis in general surgery performed with medullar conduction anesthesia].

From 1989 to 1991, 480 patients undergoing general surgery under epidural anaesthesia were included in a multicentre, comparative, randomized, open-study designed to assess whether calcium nadroparin (Fraxiparine), 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-fragmented standard heparin (Calciparine), one subcutaneous injection of 0.2 mL t.i.d. 15,000 IU per day, for the prevention of postoperative deep vein thrombosis (DVT). The 480 patients, treated in 78 centres, were randomized in two groups (Fraxiparine, n = 241; Calciparine, n = 239). In both groups, treatment was started two hours after the end of the surgical procedure. Hernia repair and prostatic surgery accounted for 60% of operations. Thromboembolic events were detected by clinical examination performed at regular time intervals and by a systematic exam (doppler and rheoplethysmography or ultrasonogram) at the end of the treatment. Both agents demonstrated a similar efficiency. There was only one case of DVT, confirmed by phlebography in the Fraxiparine group. Tolerance was good in both groups. The proportion of patients requiring a transfusion was low (3% in each group). Hematuria was relatively frequent (33% in the Fraxiparine group and 28% in the Calciparine group), however these rates were related to prostatic and urinary incontinence surgery. This study, including a wide series of patients undergoing general surgery under epidural anaesthesia, demonstrates that efficiency and tolerance of one daily injection of Fraxiparine are similar to those of three daily injections of Calciparine. It it concluded that Fraxiparine improves of the patient's comfort and decreases the nursing work load.