Comparison of 3,000 and 5,000 IU aXa/day certoparin in the prevention of deep-vein thrombosis after total hip replacement.
BACKGROUND
The aim was to investigate, whether 5,000 IUaXa/day certoparin lowers the incidence of deep vein thrombosis (DVT) in patients undergoing elective hip replacement surgery vs. 3,000 IUaXa/day. Double-blind, multicenter, randomised trial in 500 patients. Primary endpoint: incidence of symptomatic or asymptomatic DVT (bilateral ascending venography).


RESULTS
Mean age was 71 ± 10 years with a higher prevalence of previous DVT (8vs.4%) and pulmonary embolism (PE) (4vs.1%) in the high dose group. Mean duration of surgery was 82 ± 32 and 85 ± 36 min. DVT was detected in 28 (11.1%) of the low dose and 35 (14.1%) of the high dose group (p = n.s.). Combined distal-proximal DVT was observed in 5 (2%) and 4 (1.6%) patients respectively. No difference in bleeding events was found.


CONCLUSIONS
This trial confirms prior data showing that the conventional dosage of 3,000 IU aXa is effective and safe for the prevention of venous thromboembolic events after hip replacement surgery.
Institut für Pharmakologie und präventive Medizin, Menzelstrasse 21, Mahlow, 15831, Germany. peter.bramlage@ippmed.de.
Peter
P
Bramlage
Hans-Christoph
HC
Michaelis
Nima
N
Melzer