SAFETY OF ENOXAPARIN AND DEXTRAN-70 IN THE PREVENTION OF VENOUS THROMBOEMBOLISM IN DIGESTIVE SURGERY - A PLAY-THE-WINNER-DESIGNED STUDY

A total of 327 patients were included in a play-the-winner (PTW)-desig ned study comparing the safety of prophylaxis with enoxaparin and dext ran-70 in patients undergoing digestive surgery. In a PTW-designed stu dy the treatment of any next patient will depend on the outcome of the previous one. If successful, the next patient will receive the same t reatment. Excessive bleeding, on the basis of specified criteria, seve re adverse effects, or occurrence of clinically detected venous thromb oembolism was classified as failure. The PTW design allocates most pat ients to the superior treatment. In this study 200 patients were given enoxaparin and 127 dextran-70. The success rate was 83% in the enoxap arin group and 74.8% in the dextran-70 group (p = 0.05). The survival analysis of 'Number of patients before change in treatment' shows a si gnificant difference in favour of enoxaparin (p = 0.05). Enoxaparin se ems to be superior to dextran-70 as a prophylaxis in digestive surgery . The PTW model is a suitable design in such studies.