Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events

Pulmonary Embolism Clinical Trial

Official title:

Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574895
• Other study ID #: 201629
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17427
• Est. completion date: December 1, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

Inclusion Criteria:

1. All pediatric patients 0-21 years of age who are admitted to an inpatient unit of Monroe Carell Jr. Children's Hospital at Vanderbilt will be included in the study.

Exclusion Criteria:

1. Receiving prophylactic or therapeutic dosing of anticoagulants, including enoxaparin, warfarin, bivalirudin, apixaban, rivaroxaban, dabigatran, and edoxaban.

2. Patients admitted under "observation status"

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pediatrics
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• Hematology Review
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Walker SC, Creech CB, Domenico HJ, French B, Byrne DW, Wheeler AP. A Real-time Risk-Prediction Model for Pediatric Venous Thromboembolic Events. Pediatrics. 2021 Jun;147(6):e2020042325. doi: 10.1542/peds.2020-042325. Epub 2021 May 19. — View Citation

Walker SC, French B, Moore R, Domenico HJ, Wanderer JP, Balla S, Creech CB, Byrne DW, Wheeler AP. Use of a real-time risk-prediction model to identify pediatric patients at risk for thromboembolic events: study protocol for the Children's Likelihood Of Thrombosis (CLOT) trial. Trials. 2022 Oct 22;23(1):901. doi: 10.1186/s13063-022-06823-7. — View Citation

Walker SC, French B, Moore RP, Domenico HJ, Wanderer JP, Mixon AS, Creech CB, Byrne DW, Wheeler AP. Model-Guided Decision-Making for Thromboprophylaxis and Hospital-Acquired Thromboembolic Events Among Hospitalized Children and Adolescents: The CLOT Rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of VTE Events	Number of VTE events per hospital admission encounter, per study arm. A VTE event will be defined as an acute venous thromboembolic event (e.g. deep vein thrombosis, pulmonary embolism, etc).	1 year
Secondary	Total Number of Patients Started on Anticoagulation	Total number of patients, without contraindications to anticoagulant medications as described by the prescriber information for heparin and enoxaparin determined by the consulting hematologist, who are begun on prophylactic anticoagulation, by study arm	1 year
Secondary	Total Number of High-Risk Patients Started on Anticoagulation	Total number of high-risk patients, without contraindications to anticoagulant medications as described by the prescriber information for heparin and enoxaparin determined by the consulting hematologist, who are begun on prophylactic anticoagulation, by study arm	1 year
Secondary	Total Number of Patients Started On Anticoagulation If It Was Recommended	Total number of patients, without contraindications to anticoagulant medications as described by the prescriber information for heparin and enoxaparin determined by the consulting hematologist, who are begun on anticoagulation medications compared to the total number of patients for which initiation of anticoagulation was recommended by the VTE research team	1 year
Secondary	Total Number of Bleeding Events	Total number of bleeding events per number of patients begun on prophylactic anticoagulation, by study arm, during hospitalization. The bleeding events will be defined and scored using the WHO bleeding scale. Grade 1 (petechial bleeding) and 2 (mild blood loss) will be considered adverse events and grade 3 (bleeding requiring transfusion) and 4 (fatal bleeding) will be considered serious adverse events.	1 year