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

NCT04574895 | Completed

• 1 other identifier: 201629
• Study Type: interventional
• Target: 17,427
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism; Pediatrics; Deep Vein Thrombosis; Pulmonary Embolism

Keywords

Pediatric Hematology; Venous Thromboembolism; Risk Prediction Model; General Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Number of Patients Started on Anticoagulation

  1 year

• Total Number of High-Risk Patients Started on Anticoagulation

  1 year

• Total Number of Patients Started On Anticoagulation If It Was Recommended

  1 year

• Total Number of Bleeding Events

  1 year

Study Arms (2)

VTE risk prediction scores

OTHER

Patients in the intervention arm will have their VTE risk prediction scores presented to the study team daily on weekdays via an automated report, which will list patients in descending order of risk severity for review by the VTE research team each weekday. Starting with the highest risk patients, the VTE research team will review each patient and clinical situation, and then the VTE research team will directly discuss risks/benefits of prophylactic anticoagulation with the admitting team. Patients with a risk score \<2.5% will not be reviewed, and the investigators anticipate most of the intervention arm patients will fall into this category (based on our previous data, the investigators anticipate \>90% of all patients will score \<2.5%). The VTE risk report will be re-calculated based on updated EHR data every day at midnight.

Other: Hematology Review

Standard of care

NO INTERVENTION

Patients randomized to the control arm will continue to receive current standard of care anticoagulation practice, which is at the discretion of the admitting team. In general, nearly no pediatric patients are offered prophylactic anticoagulation unless a previous VTE has been identified. This currently is at the discretion of the provider and no risk scoring is used. VTE risk prediction scores will be calculated and stored for analysis, these will not be visible to the study team in real time.

Interventions

Hematology Review OTHER

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.

VTE risk prediction scores

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• Receiving prophylactic or therapeutic dosing of anticoagulants, including enoxaparin, warfarin, bivalirudin, apixaban, rivaroxaban, dabigatran, and edoxaban.
• Patients admitted under "observation status"

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related 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.

  PMID: 34011634 BACKGROUND

• 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.

  PMID: 36273203 BACKGROUND

• 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 Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2337789. doi: 10.1001/jamanetworkopen.2023.37789.

  PMID: 37831448 RESULT

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Allison P Wheeler, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• Buddy Creech, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Team biostatistician will remain blinded to the group assignments for performing outcome statistics.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: November 2, 2020
• Primary Completion: January 31, 2022
• Study Completion: December 1, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)