Fondaparinux for Prevention of Venous Thromboembolism in High-Risk Trauma Patients: A Pilot Study
Received 16 June 2009; received in revised form 30 July 2009; accepted 4 August 2009. published online 11 September 2009.
Background
Venous thromboembolic events (VTE) remain a major cause of morbidity and mortality after trauma. Fondaparinux, a synthetic, nonheparin drug, has shown promise in reducing VTE in orthopaedic patients, but has not previously been studied in trauma patients. The goal of this study was to determine the safety and efficacy of fondaparinux when incorporated into our VTE prevention protocol. We hypothesized that the occult deep vein thrombosis (DVT) rate in high-risk patients receiving fondaparinux would be <5%.
Study Design
Consented patients were assigned to a treatment group stratified by their VTE risk factors: high-risk, fondaparinux 2.5 mg subcutaneously once daily; very high-risk, both fondaparinux and pneumatic compression. Patients who were not candidates for anticoagulation received pneumatic compression only. All patients underwent surveillance venous ultrasonography imaging of upper and lower extremities on enrollment and weekly thereafter. Serum samples were analyzed for peak and trough drug concentration levels.
Results
Overall incidence of DVT among the 87 enrolled patients was 4.6%. DVT developed in only 1 of 80 patients who received fondaparinux (1.2%). One patient assigned to fondaparinux had a DVT on initial scan before receiving prophylaxis. DVT developed in two of six patients in pneumatic compression only (33%). There were no episodes of pulmonary embolism, thrombocytopenia, or bleeding attributable to fondaparinux. Serum levels indicated adequate absorption of the drug and an effective dosing regimen.
Conclusions
Fondaparinux appears to offer protection against VTE in high-risk trauma patients. Its once-daily dosing regimen can improve compliance and reduce cost and eliminate risk of heparin-induced thrombocytopenia.
Department of Surgery, University of California San Francisco, San Francisco, CA
Correspondence address: M Margaret Knudson, MD, FACS, Department of Surgery, University of California San Francisco, San Francisco General Hospital, 1001 Potrero Ave, Ward 3A, San Francisco, CA 94110
Disclosure Information: Dr Knudson has received salary support as a study coordinator and vascular technician from GlaxoSmithKline Pharmaceuticals, which also supplied the drug for the study. All other authors have nothing to disclose.
ABSTRACT