[Evaluation of the effectiveness and safety of Fragmin (Kabi 2165) versus calcium heparin in the prevention of deep venous thrombosis in general surgery]

Abstract

Fourty patients who underwent general surgery have been enrolled in a double-blind controlled trial which evaluated the efficacy and safety of Fragmin, a new low molecular weight heparin, chosen to be the 1st OMS International Standard for LMWH. Fragmin 2500 UI anti-Xa once daily and unfractionated heparin 5000 UI twice daily were administered to prevent postoperative deep venous thrombosis. Prophylaxis began two hours before surgery and continued for the next 5 postoperative days. The incidence of isotopic venous thrombosis, thromboembolic disorders and bleeding complications have been evaluated. Results have shown a similar efficacy and safety profile of the two drugs, although Fragmin doses are markedly inferior to unfractionated heparin's. Moreover, Fragmin has the advantage of a single daily administration, with a better patients' compliance and an easier and less expensive nursing care.