Pharmacodynamics of low molecular weight heparin in patients undergoing bariatric surgery: A prospective, randomised study comparing two doses of parnaparin (BAFLUX STUDY)

Background: The optimal dose of low-molecular-weight-heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. Aim: The aim of this study was to evaluate the pharmacodynamic parameters of two doses of the LMWH parnaparin administered to patients undergoing bariatric surgery. Methods: Patients were enrolled in a multicentre, open label, pilot study and were randomised to receive 4250 IU/day [n= 36; 30 females; median age: 38 years (23-56); median BMI: 46.7 Kg/m(2) (36.5-58.8)] or 6400 IU/day [n= 30; 24 females; median age: 42 years (22-63); median BMI: 43.7 Kg/m(2) (36.1-64.1)] of parnaparin s.c. for 7-11 days. The pharmacodynamic effects of parnaparin were analysed by measuring the anti Factor Xa activity on day 0 (12 hours after the first parnaparin injection), day 4 and day 6 after surgery (before and 4 hours after parnaparin administration). Results: In 98.3% of patients receiving 4250 IU/day the peak anti-Xa levels were in the range of 0.1-0.4 IU/ml. Higher anti-Xa levels were observed in patients receiving 6400 IU/day: in 62.3% of these patients the peak anti-Xa levels were greater than 0.4 IU/ml. The anti-Xa levels measured 4 hours after injection on days 4 and 6 were not statistically correlated with BMI for either dose of-parnaparin (p = 0.077 and p = 0.401 for 4250 or 6400 IU/day, respectively). Conclusion: The dose of 4250 IU/day seems adequate to achieve prophylactic anti-Xa levels in morbid obese patients undergoing bariatric surgery. Conversely, most of the patients receiving 6.400 IU/day show anti-Xa levels higher than the recommended prophylactic values. (C) 2009 Elsevier Ltd. All rights reserved.