A Pilot Study on the Randomization of Inferior Vena Cava Filter Placement for Venous Thromboembolism Prophylaxis in High-Risk Trauma Patients

• DOI: 10.1097/ta.0b013e318226ece1
• Publication Date: 2011-08-09T08:56:33Z
• Authors: Anita Rajasekhar; Lawrence Lottenberg; Richard Lottenberg; Robert J. Feezor; Scott B. Armen; Huazhi Liu; Philip A. Efron; Mark Crowther; Darwin Ang
• Keywords: Interim analysis; Trauma Center

Background: Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite lack Level I data supporting this use. We report 2-year interim analysis Filters Trauma pilot study. Methods: This is a single institution, prospective randomized controlled feasibility study center. HRTPs were identified pIVCF placement by Eastern Association Surgery guidelines. From November 2008 to 2010, enrolled and either or no pIVCF. All received pharmacologic prophylaxis when safe. Primary outcomes included objectives secondary incidence PE, deep vein thrombosis (DVT), death. Results: Thirty-four 38 eligible analysis. The baseline sociodemographic characteristics balanced between both groups. Results included: time from admission enrollment (mean, 47.4 hours ± 22.0 hours), randomization 4.8 9.1 IVCF 16.9 9.2 adherence weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF 62.5%), 1-month clinical follow-up 83.3%; 100%). At 6-month follow-up, one PE nonfilter DVT filter had occurred. One non-PE-related death occurred group. Barriers inability obtain informed consent due patient refusal next kin delayed notification eligibility status. Conclusion: Our demonstrates that trial evaluating efficacy pIVCFs feasible. will be used inform design multicenter determine receiving versus