In a prospective, randomized, double-blind study, the efficacy and
safety of a low-molecular-weight heparin were compared with those of
unfractionated sodium heparin (standard heparin) in 136 patients who had
elective total hip replacement. The patients received subcutaneous
injection of either 5000 international units of low-molecular-weight
heparin once daily or 5000 international units of standard heparin three
times a day. Treatment with low-molecular-weight heparin began twelve hours
before the operation, and treatment with standard heparin began two hours
preoperatively; both regimens were continued for ten days. Twelve days
postoperatively, bilateral ascending phlebography was performed in 122
patients, sixty-three in the treatment group that received
low-molecular-weight heparin and fifty-nine in the treatment group that
received standard heparin. Pulmonary scintigraphy was performed in 127
patients. Deep-vein thrombosis was diagnosed in forty-four patients:
nineteen (30 per cent) of the sixty-three who received low-molecular-weight
heparin and twenty-five (42 per cent) of the fifty-nine who received
standard heparin. All but four patients, two from each treatment group,
were asymptomatic. The difference in the total rate of thrombosis in the
two groups was not significant (p = 0.189). However, thrombosis occurred in
the thigh in only six (10 per cent) of the patients who received
low-molecular-weight heparin but in eighteen (31 per cent) of those who
received standard heparin, a significant difference (p = 0.011). Pulmonary
embolism was detected in twenty-seven patients: eight (12.3 per cent) of
those who received low-molecular-weight heparin and nineteen (30.6 per
cent) of those who received standard heparin. Only three patients had
clinical signs of embolism. Pulmonary embolism was significantly more
frequent in the group that received standard heparin (p = 0.016). Total
loss of blood and the total amount of blood that was transfused were
significantly reduced in the patients who received low-molecular-weight
heparin compared with those who received standard heparin. Prophylaxis was
not discontinued because of hemorrhage in any patient. The efficacy of
low-molecular-weight heparin was superior to that of standard heparin in
the prevention of femoral thrombosis and pulmonary embolism, although the
over-all incidence of deep-vein thrombosis was not statistically
different.(ABSTRACT TRUNCATED AT 400 WORDS)