An interventional study of VTE Risk Assessment CDS Tool in Venous Thromboembolism (VTE), sponsored by National Heart, Lung, and Blood Institute (NHLBI). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Prevention
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Among 220 studies in Venous Thromboembolism with a site in United States — 36 open to participants now, 39 under way, 8 of them phase 3. Venous Thromboembolism · United States.
Among the 220 studies in Venous Thromboembolism with a site in United States, this one is the 3rd largest by planned enrollment of the 165 interventional ones that give a count, is one of 11 that started in 2026, is one of 40 with no phase, reaches primary completion later than 27 of the 38 other live ones, and was the 220th registered.
713 studies on the registry are indexed under Venous Thromboembolism; 147 are open to participants now.
Browse Venous Thromboembolism studies →36 of the 220 studies in Venous Thromboembolism with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States, Bulgaria, Japan and 2 more countries
Ages 18+
The University of Texas Health Science Center, Houston · Sites in United States
Ages 18–80
Brigham and Women's Hospital · Sites in United States
Ages 18+
Regeneron Pharmaceuticals · Sites in United States, Canada
Ages 18+
Regeneron Pharmaceuticals · Sites in United States, Georgia, Japan
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 113 Venous Thromboembolism studies recruiting now, 90 (80%) set no upper age limit and 13 (12%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
220 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 33 · Phase 3 50 · Phase 4 26
First in 2001; this study’s year is marked. 11 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 65,000 is above the median of 241 across 402 interventional studies indexed under Venous Thromboembolism.
Median enrollment 218 across the 165 interventional studies, 1,187 across the 55 observational. Of the 163 that completed or were terminated, 79 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
77 of 220 have an industry lead sponsor. The 10 most frequent:
National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,144 studies on the registry; 72 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.
National Heart, Lung, and Blood Institute (NHLBI) has 7 studies filed under Venous Thromboembolism — fewer than ten, so there is no comparison to draw.
19 of the studies in Venous Thromboembolism with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07015905Phase 3Regeneron PharmaceuticalsREGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults | 2027-02-20 |
| NCT04924322Phase 3Yale UniversityCatheter-Related Early Thromboprophylaxis With Enoxaparin Studies | 2027-04-30 |
| NCT06861088Phase 3Quercis Pharma AGThe Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer | 2027-10-31 |
| NCT02832245Manuel MonrealComputerized Registry of Patients With Venous Thromboembolism (RIETE) | 2026-12 |
| NCT05683808University of Vermont Medical CenterVenous Thromboembolism Prevention in Outpatients With Glioma | 2026-12-30 |
Add all 19 to your calendar (.ics) → With an account.
Among the 220 studies in Venous Thromboembolism with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate whether the implementation of a real-time prognostic model can effectively identify and prevent blood clots among hospitalized patients. The main questions it aims to answer is:
Researchers will compare the intervention arm with the control arm (standard of care) to determine whether the intervention reduces rates of blood clots and improves initiation of preventive treatment.
The intervention (clinical decision support that displays the prognostic model's output) will be implemented by displaying a risk score in clinicians' workflow in the electronic health record (EHR) to notify clinicians of patients who are at higher risk for sustaining a blood clot. The intervention will not dictate patient care and clinicians will continue to use their clinical knowledge and judgment in their clinical decision-making.
Rationale and Specific Aims In the last 30 years, there has been no significant improvement in rates of venous thromboembolism (VTE). These blood clots develop in the limbs and can travel to the lungs and form pulmonary emboli, which are the most common cause of preventable deaths in the hospital. Currently or recently hospitalized patients account for the majority of VTE cases annually. Failure to recognize and prevent hospital-acquired VTE (HA-VTE) is considered a medical error by the Institute of Medicine. However, the current approach for predicting and preventing HA-VTE among hospitalized adults is not standardized. Clinicians can: order prophylaxis for all patients, thereby potentially harming patients who will not benefit from this intervention; use clinical judgment, which may under- or over-estimate risk and result in medical errors; or apply a risk-stratification tool based on information from the patient history and clinical scenario. Unfortunately, available risk-stratification tools were developed without sufficient input from frontline clinicians, add to clinician workload, are too cumbersome to implement in daily clinical practice, exhibit poor-to-fair prediction accuracy, and do not consider the risk of bleeding complications. Importantly, use of these tools in clinical practice has not been shown to improve patient outcomes. A significant gap therefore exists between the current system of variable practice patterns in VTE risk assessment and the goal of driving down rates of HA-VTE and reducing preventable deaths in the hospital.
Bridging this gap requires implementing an accurate, dynamic prognostic model for development of HA-VTE that is consistently and efficiently used by clinicians. Our research team has developed an automated, real-time prognostic model for HA-VTE among all adult inpatients at Vanderbilt University Medical Center based on readily available clinical factors and medical history. The model calculates the probability of HA-VTE, updates as the clinical scenario evolves, discriminates well between high- and low-risk patients, and exhibits superior prediction performance compared with extant risk-stratification tools. In parallel, the investigators conducted observations and interviews with ordering clinicians and nurses to ascertain when HA-VTE risk should be assessed, which outcomes should result from implementation of a prognostic model, what the model should include, how and when the model's output should be communicated to clinicians, what clotting versus bleeding risk factors drive prophylaxis decisions, and which implementation strategies will change clinical practice. It is unknown whether use of a prognostic model for HA-VTE in clinical practice improves patient outcomes.
Therefore, the investigators aim to: conduct a pragmatic randomized trial of the automated clinical decision support (CDS) tools based on a prognostic model for HA-VTE compared with usual care for the prevention of VTE among hospitalized adults. Through an adaptive platform trial, the investigators will evaluate on a prospective basis the effectiveness of model-guided CDS to reduce HA-VTE, both overall and among key patient subgroups, and study through randomization the implementation strategies that work best for clinicians and improve patient outcomes. In a complementary implementation evaluation, the investigators will assess acceptability, appropriateness, and feasibility of the intervention; identify barriers and facilitators to its implementation; and measure its uptake by clinicians in daily clinical practice.
Preliminary Studies In preparation for this clinical trial, the study team conducted 32 observations and 36 interviews with clinicians across multiple specialties and roles (physicians, pharmacists, nurses, physician assistants, nurse practitioners, and medical residents) to gain an understanding of current practices regarding HA-VTE risk assessment at Vanderbilt Adult Hospital and receive feedback on a previous version of the prognostic model for HA-VTE. These interviews guided refinement of the prognostic model, including variable selection. Observations and interviews were completed as part of a related IRB study (IRB #240579). Deidentified data of observations and interviews may be accessed throughout the course of this study.
Clinicians also had the opportunity to provide additional feedback through two design workshops, conducted with by the Center for Research and Innovation in Systems Safety (CRISS). Clinician feedback on visualization and implementation strategies helped inform the creation of user-friendly CDS tools that integrate the prognostic model into clinical workflows. In this next stage, the investigators plan to test whether the use of this CDS in routine clinical practice improves patient outcomes.
As part of a related IRB study (IRB #210161), the study team developed a prognostic model for HA-VTE in a derivation cohort of 132,561 patient encounters at the VUMC adult hospital (1/1/2018-12/31/2020): median age, 56 years, 52.3% female, 16.2% self-report black race, 1214 HA-VTE events (0.9%). Candidate predictor categories included demographic characteristics and social determinants of health (e.g., age, sex, race, and ethnicity), inpatient encounter details (e.g., admission type), medical history that is either active or diagnosed during the encounter (e.g., Elixhauser comorbidity details, prior history of VTE), vital signs, laboratory measurements, medications (e.g., immunoglobulins, glucocorticoids, statins), nurse-recorded information regarding mobility (e.g., Braden sub-scores, Richmond Agitation-Sedation Scale (RASS) score), and environmental factors (e.g., Neighborhood Atlas's rankings on socioeconomic disadvantage). Presence of HA-VTE between hospital admission and discharge was defined using ICD-10 diagnosis codes. Least absolute shrinkage and selection operator (LASSO) regression with tenfold cross-validation was used for variable selection to select the subgroup of variables minimizing cross-validation error. The investigators used the area under the receiver operating characteristic curve (AUC) as the error measure to be optimized in the cross-validation process. Clinician feedback regarding model complexity and variables necessary for inclusion was also incorporated into the identification of the final prognostic model. Variables selected in the LASSO procedure plus those suggested by clinicians were included in an unpenalized multivariable logistic regression model to formulate the prognostic model.
From the set of 105 potential predictors, the LASSO procedure identified 11 variables (in decreasing order of importance): presence of a central line, oxygen flow, glucocorticoids ordered encounter, fibrinogen, lactate, admission type (elective admissions, through the emergency department, for trauma, interhospital transfer), immunoglobulins ordered during encounter, respiratory rate, Braden mobility sub-score, Braden perception sub-score, and Braden nutrition sub-score. Clinician feedback identified 6 variables: age, sex, coagulopathy comorbidity, blood loss comorbidity, history of cancer, and history of thrombosis. The prediction performance of the resultant logistic regression model with 17 variables was evaluated in a temporal external validation cohort of 171,891 patient encounters at the VUMC adult hospital (1/1/2021-10/31/2024): median age, 56 years, 52.9% female, 15.9% self-report black race, 2230 HA-VTE events (1.3%). The AUC was 0.892 (95% CI: 0.886, 0.897), indicating excellent discrimination accuracy.
The logistic regression model with 17 variables will be implemented in the CDS intervention(s) in the trial to calculate a patient's predicted probability of HA-VTE during the encounter. The predicted probability of HA-VTE will be categorized as: less than 0.01 (or 1%) as "low"; greater than or equal to 0.01 (or 1%) to less than 0.02 (or 2%) as "elevated"; and greater than or equal to 0.02 (or 2%) as "critically high." For patients randomized to the intervention, clinicians will see a visualization of this predicted probability when assessing a patient risk's for HA-VTE.
Enrollment and Randomization Participant screening will be performed using predefined eligibility criteria applied to data contained within the EHR.. Eligible patients will be identified through an EHR-based data query developed and maintained by the Vanderbilt Clinical Informatics Center (VCLIC) core team. All adult patients receiving routine inpatient care at VUH will be eligible for inclusion in this trial (standard of care dictates that all admitted patient encounters include DVT/VTE prophylaxis set as part of admitting orders). Randomization will occur through a built-in functionality in the EHR at the patient level. The clinical decision regarding randomization between the two treatment arms will be arbitrary, meaning randomization will not be based on clinical factors.
For patients randomized to the intervention arm, clinical teams will be shown the HA-VTE risk score in their EHR workflow, and for patients randomized to the control, the clinical team will not see a risk score but follow standard of care assessment of HA-VTE and prophylaxis per current workflows. Current standard of care dictates that all patients admitted to the inpatient setting at Vanderbilt Adult Hospital are assessed for VTE risk on admission. This risk assessment tools and process differ by service, but all services assess risk as part of their protocols.
Study Design and Statistical Considerations This is an adaptive platform trial (APT), which is designed to incorporate learning as it occurs and focuses on improving the outcome, rather than on a particular intervention. Intervention components may be modified, removed, or added over time based on predefined decision rules. APTs can yield several important benefits to patients and researchers: components that lack efficacy can be abandoned or replaced; and treatment effects can be estimated with greater statistical precision. The investigators plan to conduct interim analyses every three months to evaluate the intervention and decide on any modifications.
For interim analyses, the study team will use a quality outcome: model-indicated prescription of HA-VTE prophylaxis (i.e., implementation among high-risk patients but not among low-risk patients). A readily defined, proximal binary outcome will facilitate timely within-trial adaptations. Use of an intermediate outcome is appropriate given the strong association between the intermediate outcome (e.g., thromboprophylaxis) and the primary outcome (e.g., HA-VTE). At each interim analysis, an odds ratio will be calculated to compare the odds of model-indicated prescription of HA-VTE prophylaxis between the intervention and control groups. If the posterior probability that the odds ratio is greater than a minimum clinically relevant difference (e.g., greater than 1.05) is high (e.g., greater than 95%), the current implementation of the intervention will be accepted as effective and it will be adopted for the duration of the trial. If the posterior probability that the odds ratio is greater than a minimum clinically relevant difference (e.g., greater than 1.05) is small (e.g., less than 20%), the current implementation of the intervention will be abandoned due to futility and subsequently new implementation of the intervention will be adopted. Interim analyses will occur every 3 months, subject to sufficient enrollment to support interim analyses.
The final analysis will compare the odds of HA-VTE between the final implementation of the intervention and the common control group of patients. Patients will be analyzed according to the group to which they were randomized regardless of whether HA-VTE prophylaxis was ordered (i.e., intent to treat). The investigators will calculate the Bayesian posterior probability that the odds ratio is less than 1.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For patients randomized to the control arm, the clinical care team will administer standard of care at VUH and monitor their patients' risk for HA-VTE in accordance with existing protocols and procedures. Standard of care includes assessing patient risk for VTE and initiating prophylaxis if necessary, usually using an order set. If the clinical care team determines that the patient has elevated risk and no contraindications, they will initiate and order prophylaxis using their service line-specific order set and continue to monitor the patient for any complications. Providers caring for patients in the control arm will not be shown the HA-VTE risk score anywhere in the EHR, which is the status quo.
Standard of care plus risk assessment model: the prognostic model will automatically calculate a patient's risk score daily based on 17 risk factors. For patients randomized to the intervention, the clinical care team will see the patient's predicted risk score during their standard risk assessment process, which will be embedded in their EHR workflow. The clinical care team will have access to review the patient's risk score in conjunction with their clinical judgment to guide decision-making surrounding risk assessment and initiation of prophylaxis (if applicable).
Other: VTE Risk Assessment CDS Tool
This intervention includes a risk assessment CDS tool that is embedded in EPIC workflow for clinicians. This tool may be located in different areas in EPIC based on clinician role to increase ease of access. The tool, which is based on 17 risk factors, will automatically calculate a patient's risk score and present that risk score to clinicians. Clinicians will have the opportunity to review this risk score during their risk assessment of patients to help guide decision-making surrounding initiation of prophylaxis (if applicable). Unlike other tools, this tool will update patient risk every 24hours and notify clinicians of the updated risk. This tool will also present for all inpatients at the facility, not just high-risk patients.
Occurrence of HA-VTE
Occurence of HA-VTE during hospitalization, identified by diagnostic codes.
Time frame: Day 1 (date of patient admission to hospital) until date of discharge from hospital or up to 6 months.
VTE related visits to a VUMC facility
Any VTE related visits to a VUMC facility within 90 days post-discharge, as identified by encounter data in the EHR.
Time frame: 90 days post-discharge from hospital
Number of participants who receive pharmacological prophylaxis
total number of participants for whom any pharmacological prophylaxis is ordered and administer during hospitalization, defined as the administration of at least 1 dose of the following medications indicated in the MAR (Medication Administration Record) within the electronic health record : APIXABAN BETRIXABAN EDOXABAN RIVAROXABAN DABIGATRAN WARFARIN DALTEPARIN ENOXAPARIN HEPARIN FONDAPARINUX ARGATROBAN BIVALIRUDIN ASPIRIN
Time frame: Day 1 (date of patient admission to hospital) until date of discharge from hospital or up to 6 months.
Number of participants who receive non-pharmacological prophylaxis
Total number of participants for whom any non-pharmacological intervention is administered during hospitalized (i.e. SCD, ambulation), as indicated by documentation in nursing vascular perfusion flowsheet in the electronic health record: Nursing documentation of ambulation Nursing documentation of SCDs applied to patient
Time frame: Day 1 (date of patient admission to hospital) until date of discharge from hospital or up to 6 months.
Major Bleeding complications
Any major bleeding complications that occur during hospitalization of patient, as defined through the following : * Diagnostic Codes or bleeding (any diagnosis of bleeding at discharge (intracranial, gastrointestinal, hematuria, airway bleeding, anemia due to bleeding/iron deficiency, hemopericardium, and gynecological bleeding) ) * Orders for transfusion (bleeding leading to transfusion of two or more units of whole blood or red cells.) * Lab values indicating a fall in hemoglobin level of 20 g/L-1 (1.24 mmol/L-1) or more
Time frame: Day 1 (date of patient admission to hospital) until date of discharge from hospital or up to 6 months.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in venous thromboembolism and/or model implementation. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be available upon request starting 3 months after article publication and the data will be made accessible for up to 24 months.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and institutional approval of a research proposal, a Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 65 non-industry interventional studies with no phase under Venous Thromboembolism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 19 months is below that.
Counting every sponsor, half of 70 studies reached it within 31 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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National Heart, Lung, and Blood Institute (NHLBI) →