EFFICACY AND SAFETY OF FRAXIPARINE(R) IN THE PREVENTION OF THROMBOEMBOLIC EVENTS IN LUNG-CANCER SURGERY

A French multicentre, open, randomized trial was conducted in lung can cer surgery in order to test the optimal dosage regimen: Fraxiparine(R ) 3075 IU AXa (fixed dosage) and Fraxiparine 4100 or 6150 IU AXa(dosag e adjusted for body weight only), over a period of 8 days. 75 patients were allocated to each group. Efficacy (Doppler ultrasonography at D0 and D8, controlled by bilateral ascending phlebography when positive) and safety, i.e. perioperative blood loss and postoperative bleeding complications were the main assessment criteria. The efficacy of the t wo treatment regimens was confirmed = no deep Vein thrombosis and/or p ulmonary embolism. No significant difference of safety was observed be tween the two groups; nevertheless fewer patients developed major blee ding complications in the Fraxiparine(R) fixed dosage group (2 patient s) than in the Fraxiparine(R) adjusted dosage group (6 patients). Bloo d loss was comparable in the 2 groups; a statistical difference (p = 0 ,09) was showed between D0 and D2 in favour of Fraxiparine fixed dosag e group. The results of this trial indicate that Fraxiparine(R) admini stred at fixed dosage represents an effective and safe prophylaxis aga inst fatal thromboembolism in patients undergoing oncologic thoracic s urgery.