Abstract
Purpose: A randomized study using three anticoagulants for prevention of venous thromboembolism (VTE) was designed to clarify the utility and adverse events for high risk patients after major abdominal-pelvic surgery. Based on the results of a random clinical trial (RCT), Enoxaparin has been provided for high risk patients after major abdominal-pelvic surgery since April, 2012 and clinical outcomes were evaluated. Patients and methods: RCT protocol: Three hundred and three high risk patients who underwent major abdomino-pelvic surgery were randomly divided into three groups as follows: Enoxaparin 2,000 IU×2/day 7 days: Group E (n=99), Fondaparinux 2.5 mg×1/day 7 days: Group F (n=101), and unfractionated heparin 5000 U×2/day 7 days: Group H (n=103). All patients received unfractionated heparin 5000 IU intravenously for 24 hours just after the operation. The clinical outcomes were recorded in the 152 high risk patients who underwent abdomino-pelvic major surgery and who had received Enoxaparin (2000 IU×2/day 7 days). Results: RCT: Symptomatic VTE was not confirmed in any of the three groups. Anti-coagulant therapy was interrupted by hemorrhagic adverse events in Groups E, F, H as follows: n=9 (9.1%), n=9 (8.9%), and n=11 (10.7%), respectively, including one re-operation in Group H. No epidural catheter was inserted in patients from Group F based on the instructions of the Department of Anesthesiology. Conclusion: All three drugs were useful to prevent VTE. Based on our results, Enoxaparin could become a first choice drug.