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

Shannon C Walker; Benjamin French; Ryan Moore; Henry J Domenico; Jonathan P Wanderer; Sreenivasa Balla; C Buddy Creech; Daniel W Byrne; Allison P Wheeler

doi:10.1186/s13063-022-06823-7

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.

Authors

Shannon C Walker^{1

2}, Benjamin French³, Ryan Moore³, Henry J Domenico³, Jonathan P Wanderer⁴, Sreenivasa Balla⁵, C Buddy Creech⁶, Daniel W Byrne³, Allison P Wheeler⁷

Affiliations

¹ Division of Pediatric Hematology/Oncology, Vanderbilt University Medical Center, Nashville, USA. shannon.walker@vumc.org.
² Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, USA. shannon.walker@vumc.org.
³ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, USA.
⁴ Department of Anesthesiology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, USA.
⁵ HealthIT, Vanderbilt University Medical Center, Nashville, USA.
⁶ Vanderbilt Vaccine Research Program and Division of Pediatric Infectious Diseases, Vanderbilt University Medical Center, Nashville, USA.
⁷ Division of Pediatric Hematology/Oncology, Vanderbilt University Medical Center, Nashville, USA.

Abstract

Background: Pediatric patients have increasing rates of hospital-associated venous thromboembolism (HA-VTE), and while several risk-prediction models have been developed, few are designed to assess all general pediatric patients, and none has been shown to improve patient outcomes when implemented in routine clinical care.

Methods: The Children's Likelihood Of Thrombosis (CLOT) trial is an ongoing pragmatic randomized trial being conducted starting November 2, 2020, in the inpatient units at Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, TN, USA. All admitted patients who are 21 years of age and younger are automatically enrolled in the trial and randomly assigned to receive either the current standard-of-care anticoagulation practice or the study intervention. Patients randomized to the intervention arm are assigned an HA-VTE risk probability that is calculated from a validated VTE risk-prediction model; the model is updated daily with the most recent clinical information. Patients in the intervention arm with elevated risk (predicted probability of HA-VTE ≥ 0.025) have an additional review of their clinical course by a team of dedicated hematologists, who make recommendations including pharmacologic prophylaxis with anticoagulation, if appropriate. The anticipated enrollment is approximately 15,000 patients. The primary outcome is the occurrence of HA-VTE. Secondary outcomes include initiation of anticoagulation, reasons for not initiating anticoagulation among patients for whom it was recommended, and adverse bleeding events. Subgroup analyses will be conducted among patients with elevated HA-VTE risk.

Discussion: This ongoing pragmatic randomized trial will provide a prospective assessment of a pediatric risk-prediction tool used to identify hospitalized patients at elevated risk of developing HA-VTE. TRIAL REGISTRATION: ClinicalTrials.gov NCT04574895. Registered on September 28, 2020. Date of first patient enrollment: November 2, 2020.

Keywords: Hematology; Pediatrics; Pragmatic trials; Study design and best practice.

Publication types

Clinical Trial Protocol

MeSH terms

Anticoagulants / adverse effects
Child
Humans
Pragmatic Clinical Trials as Topic
Probability
Prospective Studies
Randomized Controlled Trials as Topic
Thrombosis*
Venous Thromboembolism* / diagnosis
Venous Thromboembolism* / etiology
Venous Thromboembolism* / prevention & control

Substances

Anticoagulants

Associated data

ClinicalTrials.gov/NCT04574895