Comparison of 3,000 IU aXa of the low molecular weight heparin Certoparin with 5,000 IU aXa in prevention of deep vein thrombosis after total hip replacement - German Thrombosis Study Group

Background. The aim of this randomized, double-blind and prospective clinic al trial was to investigate whether an increase of the conventional daily d osage (3,000 IU aXa) of the low molecular weight heparin certoparin up to 5 ,000 IU aXa/day might lower the incidence of deep vein thrombosis (DVT) in patients undergoing elective hip surgery. Methods. The main criterium of this trial was the incidence of DVT diagnose d by bilateral ascending venography, which was performed either if DVT was clinically suspected or in each remaining patient between the 12(th) and th e 14(th) post-operative day. A total number of 172 patients were enrolled t o receive the conventional dosage of 3,000 IU aXa (Mono-Embolex NM(R)) and 169 patients to receive the high dosage form (5,000 IU aXa) once daily. The mean age (+/-SD) was 69.6+/-9.5 and 67+/-11.7 years. Results. No relevant differences were found concerning predisposing risk fa ctors. The duration of surgery was 93+/-25.2 and 88+/-21.4 min (mean+/-SD). Surgical type and approach were not different between the groups. Deep vei n thrombosis was detected in 17 patients (9.9%) in the conventional dose gr oup and in 16 patients (9.5%) in the high dose group (intent-to-treat analy sis; n.s.). The rate of bleeding complications was not significantly differ ent except the cell saver volumes (770+/-136 vs 475+/-186 ml; p<0.001). No significant difference was found in the serious adverse event reporting alo ng the lines of EC-GCP (10 vs 8 events; p=0.65). Conclusions. This clinical trial confirmed that the conventional dosage (3, 000 IU aXa/day) of certoparin ensures maximal antithrombotic activity.