We assessed the safety and efficacy of the novel low molecular weight
heparinoid Lomoparan (
Org 10172) for the prevention of
deep-vein thrombosis in patients undergoing elective
total hip replacement in a randomized, placebo-controlled, double-blind trial in 197 consecutive patients. The
heparinoid (750 anti-
factor Xa-units, s.c., b.i.d.) was administered to 97 patients and 99 patients received placebo. Study medication was started preoperatively and continued for 10 days. Efficacy was assessed by bilateral phlebography at day 10, postoperatively. The incidence of
deep-vein thrombosis was 56.6% and 15.5% respectively in the placebo and
heparinoid treated patients (incidence reduction: 74%; P less than 0.001). This reduction was observed both for proximal-vein
thrombosis (25% to 8%; P less than 0.005) and isolated calf-vein
thrombosis (31% to 7%; P less than 0.001). No major
hemorrhage was observed. The number of red-cell units transfused and drain-fluid loss were comparable for the two study groups. Six patients in the
heparinoid group and none in the control group developed minor
wound hematomas (P less than 0.05). During an 8-week post-discharge follow-up period three patients with a normal venogram at day 10 developed clinically apparent
venous thromboembolism, which was confirmed by objective testing. All three patients belonged to the
heparinoid-treated group. We conclude that 750 anti-
factor Xa units
Org 10172 s.c. twice daily starting preoperatively is safe and effectively reduces early
deep-vein thrombosis following elective
total hip replacement. Further studies on the incidence of post-discharge
thromboembolism are required.