Early clinical experience of a new heparinoid, Org 10172, in prevention of deep venous thrombosis.
The potential antithrombotic effect of a new low molecular weight heparinoid, Org 10172, was examined in a randomized, double-blind, placebo-controlled, dose-ranging pilot study of the prevention of deep venous thrombosis (DVT) in 45 high-risk patients having major thoracic or abdominal surgery for cancer. Org 10172 was given in doses of 500, 750 or 1000 U bd subcutaneously. DVT occurred in 9 of 14 patients given placebo and in 4 of 11 patients given 500 U bd but in none of the 20 patients given 750 or 1000 U bd. Operative blood loss and post-operative bleeding were not significantly different between the groups but one patient given 1000 U bd had major post-operative bleeding. Average mid-interval and trough plasma anti-Xa levels reached 0.26 and 0.20 U/ml respectively following the highest dose. It is concluded that Org 10172 is a potentially useful antithrombotic agent and that the effective and safe dose appears to be between 500 and 1000 U bd for prevention of DVT in high-risk patients.
D000368:Aged; D000369:Aged, 80 and over; D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D005170:Factor X / Q000037:antagonists & inhibitors; D015951:Factor Xa; D005260:Female; D006025:Glycosaminoglycans / Q000008:administration & dosage / Q000627:therapeutic use*; D006470:Hemorrhage / Q000150:complications; D006497:Heparan Sulfate; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000601:surgery; D010865:Pilot Projects; D012107:Research Design; D013903:Thoracic Surgery; D013924:Thrombophlebitis / Q000517:prevention & control*
D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D005170:Factor X; D015951:Factor Xa; D006025:Glycosaminoglycans; D006497:Heparan Sulfate; C035838:danaparoid