The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Trauma patients are at high risk of developing deep vein thrombosis (DVT) and pulmonary
embolism (PE). The incidence of DVT varies greatly from 5-63% among studies depending on
patient's individual risk factors, modality of prophylaxis, and methods of detection. The
incidence of PE may be as low (0.3-4.3%) but carries a mortality of 20-50% which makes
prevention of DVT of the utmost importance. The current standard of care for DVT prophylaxis
in the trauma patient with high risk of DVT is enoxaparin, a low molecular weight heparin,
administered twice a day as long as anticoagulation in not contraindicated. Many studies have
demonstrated its efficacy when compared to mechanical compression and to unfractionated
heparin, however one of the most robust of these studies still reported an DVT incidence of
35% in patients treated with enoxaparin. Another drug, fondaparinux, is a selective factor Xa
inhibitor that could offer added benefits over enoxaparin such as once daily dosing and a
drastically reduced risk of heparin induced thrombocytopenia (HIT). Fondaparinux has been
already be widely used in post-operative hip surgery and major knee surgery patients with
good results. It has also been shown to be effective in DVT prophylaxis in patients who have
had major abdominal surgery and also in acute medical patients. Fondaparinux has yet to be
used in trauma patients. Trauma patients are a diverse and distinct population given the
acuity of their injuries and their increased risk of bleeding who at this time still do not
have a perfect method for DVT prophylaxis. We hypothesize that fondaparinux will be effective
in decreasing the risk of DVT when used in the trauma patient population. This is a non
randomized prospective cohort study designed to test the efficacy of fondaparinux in the
prophylaxis of DVT and PE in trauma patients.