Venous ThromboembolismNCT04574895
Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events
A study testing Hematology Review in people with Venous Thromboembolism and Pediatrics, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Venous Thromboembolism, Pediatrics, Deep Vein Thrombosis
- What is being tested?
- Hematology Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,427 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Receiving prophylactic or therapeutic dosing of anticoagulants, including enoxaparin, warfarin, bivalirudin, apixaban, rivaroxaban, dabigatran, and edoxaban.
- Patients admitted under "observation status"
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism Events
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.
Read the 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.
- Being tested
- Hematology Review
- Keywords
- Pediatric Hematology, Venous Thromboembolism, Risk Prediction Model, General Pediatrics
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematology ReviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start2 Nov 2020
- Primary completion31 Jan 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17,427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Walker, Vanderbilt University Medical Center
- Investigators
- Allison P Wheeler, MD, Study director, Vanderbilt University Medical CenterBuddy Creech, MD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574895
- Sponsor's protocol ID
- 201629
- Status last verified
- Dec 2023
- First submitted
- 28 Sep 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34011634Walker 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.
PubMed 36273203Walker 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.
PubMed 37831448
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism Events
- ClinicalTrials.gov ID
- NCT04574895
- Acronym / sponsor ID
- 201629
- Keywords
- Pediatric Hematology, Venous Thromboembolism, Risk Prediction Model, General Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,427 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VTE risk prediction scores | Other | Other: Hematology ReviewPatients 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. |
| 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. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Receiving prophylactic or therapeutic dosing of anticoagulants, including enoxaparin, warfarin, bivalirudin, apixaban, rivaroxaban, dabigatran, and edoxaban.
- Patients admitted under "observation status"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematology ReviewVTE 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. | Other | VTE risk prediction scores |
Primary outcome
Number of VTE Events
Time frame: 1 year
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).
4 secondary outcomes
Total Number of Patients Started on Anticoagulation
Time frame: 1 year
Total Number of High-Risk Patients Started on Anticoagulation
Time frame: 1 year
Total Number of Patients Started On Anticoagulation If It Was Recommended
Time frame: 1 year
Total Number of Bleeding Events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 34011634Walker 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.
- Background: PubMed 36273203Walker 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.
- Results publication: PubMed 37831448Walker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison P Wheeler, MD study director
Vanderbilt University Medical Center
Buddy Creech, MD study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematology Review in people with Venous Thromboembolism and Pediatrics, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of VTE Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574895, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.