ORGARAN (ORG-10172) OR HEPARIN FOR PREVENTING VENOUS THROMBOSIS AFTERELECTIVE SURGERY FOR MALIGNANT DISEASE - A DOUBLE-BLIND, RANDOMIZED, MULTICENTER COMPARISON

This double-blind, randomised, multicentre trial in 513 patients havin g elective surgery for intra-abdominal or intrathoracic malignancy com pared the efficacy and safety of venous thrombosis (VT) prophylaxis us ing 750 anti-factor Xa units of Orgaran (a mixture of low molecular we ight heparinoids) given subcutaneously (sc) twice-daily with that of t wice-daily injections of 5,000 units standard heparin. The main study end-points were the development of postoperative VT detected by I-125- fibrinogen leg scanning, and the onset of clinically significant venou s thromboembolism or bleeding. ''Intent to treat'' analysis showed a s tatistically non-significant trend towards less VT during Orgaran prop hylaxis (10.4%) than after heparin (14.9%) and there was no difference in bleeding complications between the two study groups. Results remai ned similar if only patients who completed the intended course of ther apy (''compliant patients'') were analysed. Other trials have shown th at Orgaran prevents VT after hip surgery and stroke. We now show it is also safe and effective in patients having major surgery for cancer.