Clinical efficacy of low molecular weight heparin in postoperative thrombosis prophylaxis.

Abstract

In a randomized controlled clinical trial, the efficacy and safety of two low molecular weight heparin ( LMWH ) fractions in the prophylaxis of deep vein thrombosis (DVT) were assessed. One hundred twenty-six patients undergoing major abdominal surgery received alternatively 2,500 APTT units b.i.d. of two LMWH fractions or 5,000 APTT units b.i.d. of an unfractionated sodium mucosal heparin ( UFH ). LMWH 2 differed from LMWH 1 by presenting a lower mean molecular weight and a higher anti-Xa/APTT ratio in vitro. Patients were randomly allocated to the three groups, and the development of DVT was studied with the 125I-fibrinogen uptake test ( RFUT ). The study was interrupted and the code broken prematurely because of otherwise unexplainable bleeding events. While no thrombosis and no severe bleeding were detected in the UFH group, three (7%) RFUT -positive DVT and two (5%) hemorrhagic complications occurred in the LMWH 1 group. No thrombosis and nine (22%) cases of severe bleeding were observed in the LMWH 2 group. Thus, the latter group differed significantly from the control group with regard to subjective and objective criteria for postoperative bleeding. Although these results do not allow general conclusions as to the value of LMWH fractions in the prevention of DVT, they indicate that these preparations just as ordinary heparin have a limited therapeutic range.