Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events
Condition: Venous Thromboembolism; Pediatrics; Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Interventional

Summary: 
      The study will evaluate the effectiveness of a novel, real-time risk prediction model for
      identifying pediatric patients at risk for developing in-hospital blood clots (or venous
      thromboembolism [VTE]) based on data easily extracted from the electronic medical record. The
      study will assess whether using the risk percentages for developing VTE derived from the
      model increases the number of high-risk patients screened by the pediatric hematology team,
      which may may lead to an overall reduction in the number of pediatric VTEs seen at Monroe
      Carell Jr. Children's Hospital at Vanderbilt.
    

Detailed description: 
      VTE risk factors in adult hospitalized patients are well established and prevention
      strategies have been implemented for many years. Unfortunately, VTE prevention guidelines are
      not well established in children, and the pathophysiology of pediatric VTE is sufficiently
      different from adults that adult studies cannot be extrapolated to pediatrics. There are no
      randomized trials in pediatrics to determine whether a risk prediction model helps prevent
      pediatric VTEs.

      A risk prediction model was developed that can be applied at admission and updated daily to
      predict pediatric patients at higher risk for developing a VTE. This model was developed from
      electronically extracted data from all admissions to the Monroe Carell Jr. Children's
      Hospital at Vanderbilt from January 1, 2010 to October 31, 2017. Cases were identified based
      on ICD-9/10 codes. Potential covariates were identified from previous studies and known risk
      factors for VTE development. The variables with the highest adjusted odds ratio (OR) for
      developing VTE were history of thrombosis (OR 8.7, 95% confidence interval (CI) 6.6-11.3,
      p<0.01), presence of a central venous line (OR 4.9, 95%CI 4.0-5.8, p<0.01), and cardiology
      consultation (OR 4.0, 95%CI 3.3-4.8, p<0.01). Additional significant variables include
      whether a blood gas was performed, infectious disease consultation, diagnosis of cancer, age,
      mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), lactate,
      and whether surgery was performed.

      There have been several smaller pediatric VTE risk prediction models that have been developed
      and published. However, none of these have been evaluated for efficacy in a prospective
      trial, and none of these studies have used a randomized trial approach to evaluate benefit in
      identifying pediatric patients at high risk for developing VTE. Therefore, the investigators
      are performing a randomized, pragmatic trial to evaluate the pediatric VTE risk prediction
      model and its efficacy at predicting pediatric patients at higher risk for developing a VTE.
    

Intervention name(s): Hematology Review
Intervention type(s): Other
Intervention description(s): VTE study team will review VTE risk percentages provided via automated report daily on weekdays and approach the primary team directly if the patient is appropriate for clinical antithrombotic interventions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Pediatric Hematology; Venous Thromboembolism; Risk Prediction Model; General Pediatrics