A randomized double-blind study between a low molecular weight heparin Kabi 2165 and standard heparin in the prevention of deep vein thrombosis in general surgery. A French multicenter trial.
The safety and efficacy of a low molecular weight heparin fragment Kabi 2165, given in the dose 2,500 anti-Xa units once daily, in preventing postoperative venous thromboembolism, was assessed against calcium heparin in the dose 5,000 IU twice daily, in a multicenter double blind randomized study. On an intention to treat basis 385 patients scheduled for major surgery were included in this study. Six patients (3.1%) out of 195 developed isotopic DVT in the Kabi 2165 group. Corresponding figures for calcium heparin was 7 patients (3.7%). There was no statistically significant difference between the two groups with respect to the bleeding variables; blood loss during operation, postoperative drainage, blood transfusion, haemoglobin and haematocrit levels; wound haematoma and haematoma at the injection sites. No patient had to undergo evacuation of wound haematoma or reoperation due to bleeding. It is concluded that one single daily injection of Kabi 2165 provides a convenient safe and effective prophylaxis against thromboembolism in general surgery.
Caen
J P
JP
Unité 150 INSERM, Hôpital Lariboisière, Paris, France.
D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006493:Heparin / Q000008:administration & dosage / Q000494:pharmacology*; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011897:Random Allocation; D013924:Thrombophlebitis / Q000517:prevention & control*
D006495:Heparin, Low-Molecular-Weight; D006493:Heparin