Optimal prophylactic method of venous thromboembolism for gastrectomy in Korean patients: an interim analysis of prospective randomized trial.

BACKGROUND: Whereas routine prophylaxis for venous thromboembolism (VTE) is frequently utilized in the West, Asian physicians employ it much less often, based on its recorded rarity amongst their patients. This study was designed to examine the incidence of VTE and to determine the optimal method of thromboembolic prophylaxis following gastrectomy for cancer.
METHODS: In this prospective, randomized trial, patients were assigned to either an intermittent pneumatic compression (IPC) only or an IPC plus enoxaparin. The primary end point of this study was to determine the VTE incidence rate within 30 days of surgery. A history with physical examinations for VTE and a serum d-dimer test was scheduled on postoperative days (POD) 0, 1, 4, and 7. Duplex ultrasonography (DUS) was performed as an objective test for deep vein thrombosis at POD 4. An interim analysis was performed to determine if it was ethical to continue the study. This clinical trial was registered at www.clinicaltrials.gov (NCT01448746).
RESULTS: Among the 220 patients, 3 (all from the IPC group) were diagnosed with VTE; these cases were asymptomatic, having been detected only on DUS 4 days after surgery. Postoperative bleeding occurred in 12 cases, among which 11 patients were in the IPC plus enoxaparin group.
CONCLUSIONS: This interim analysis showed a higher incidence of VTE in the IPC group but a higher bleeding rate in the IPC plus enoxaparin group. We expect that this study, once completed, will provide information key to the determination of the optimal method for preventing VTE in Korean gastric cancer patients.

RCT Entities:   Population Interventions Outcomes