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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    15000
  • sponsor
    Vanderbilt University Medical Center
Updated on 26 January 2021

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.

Details
Condition Pulmonary Disease, Venous Thrombosis, Venous Thromboembolism, Pulmonary Embolism, Thromboembolism, Thrombosis, Pediatrics, Blood Clots, Lung Disease, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis, lung embolism
Treatment Hematology Review
Clinical Study IdentifierNCT04574895
SponsorVanderbilt University Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 21 yrs?
Gender: Male or Female
Do you have any of these conditions: Pediatrics or Lung Disease or deep venous thrombosis or Pulmonary Disease or Venous Thromboembolism or Blood Clots or Venous Thrombosis or Thromboembo...?
Do you have any of these conditions: Deep Vein Thrombosis or Blood Clots or Thrombosis or lung embolism or Pulmonary Disease or Lung Disease or Thromboembolism or Venous Thromboembolism o...?
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

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

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note