title: A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.
abstract: BACKGROUND
  Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study.
  
  
  METHODS
  This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death.
  
  
  RESULTS
  Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status.
  
  
  CONCLUSIONS
  Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.
authors.affiliation: Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida 32611, USA.
authors.forename: Anita
authors.initials: A
authors.lastname: Rajasekhar
authors.forename: Lawrence
authors.initials: L
authors.lastname: Lottenberg
authors.forename: Richard
authors.initials: R
authors.lastname: Lottenberg
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Feezor
authors.forename: Scott B
authors.initials: SB
authors.lastname: Armen
authors.forename: Huazhi
authors.initials: H
authors.lastname: Liu
authors.forename: Philip A
authors.initials: PA
authors.lastname: Efron
authors.forename: Mark
authors.initials: M
authors.lastname: Crowther
authors.forename: Darwin
authors.initials: D
authors.lastname: Ang
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000453:epidemiology* / Q000517:prevention & control*; D012307:Risk Factors; D016306:Vena Cava Filters; D014947:Wounds and Injuries / Q000453:epidemiology*; D055815:Young Adult
chemical_list: D000925:Anticoagulants