Controlled clinical study of the efficacy of a new low molecular weight heparin administered subcutaneously to prevent post-operative deep venous thrombosis.
A double-blind, placebo-controlled study was carried out in 100 patients undergoing major surgery to investigate the efficacy of a new low molecular weight heparin (LMWH) preparation in the prevention of deep venous thrombosis. Patients were allocated at random to receive either placebo or LMWH (7500 AXaU) each day by subcutaneous injection (abdominal fold method), starting 2 hours before the operation and continuing for the following 7 days. Clinical and laboratory tests revealed deep venous thrombosis in 3 (6%) patients in the placebo group whereas no thrombotic episodes were observed in any of the patients treated with LMWH. Blood loss during the peri-operative and post-operative period and the number of blood units transfused were not significantly different in the two groups. Moreover, no side-effects were revealed in the LMWH group that could be attributed to the drug.
Valle
I
I
Division of Surgery, Hospital of Genova-Sestri, Italy.
Sola
G
G
Origone
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001803:Blood Transfusion; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005170:Factor X / Q000037:antagonists & inhibitors; D005260:Female; D006470:Hemorrhage; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010314:Partial Thromboplastin Time; D011183:Postoperative Complications / Q000517:prevention & control*; D011897:Random Allocation; D013927:Thrombosis / Q000517:prevention & control*
D006495:Heparin, Low-Molecular-Weight; D005170:Factor X