The MInimizing RIsk of CLotting Events Trial
Key facts
- Who runs it
- National Heart, Lung, and Blood Institute (NHLBI)
- Where
- Nashville, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 65,000 people, planned
- Started
- Nov 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- VTE Risk Assessment CDS Tool
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 18 years of age
- Admitted to an inpatient setting at Vanderbilt Adult Hospital within study period
Who cannot take part
- Under the age of 18
Where in United States
- Vanderbilt Adult HospitalNashville, United StatesContact: Benjamin French, PhDNot yet recruiting
About the trial
What the trial wants to find out
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:
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1. Can the prognostic model reduce rates of hospital-acquired blood clots (also known as hospital-acquired venous thromboembolisms)? 2. Is the prognostic model an effective tool for initiating timely and appropriate preventive treatment (i.e., thromboprophylaxis)?
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.
The 2 groups in the trial
- Control: Standard of CareNo study treatment, for comparison
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.
- Intervention: Standard of Care PLUS risk assessment modelExisting treatment, for comparison
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).
Treatment: VTE Risk Assessment CDS Tool
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimizing the Implementation of Personalized Risk-prediction Models for Venous Thromboembolism Among Hospitalized Adults: The MInimizing RIsk of CLotting Events (MIRICLE) Trial
- Record updated
- 12 November 2026