N/A
N=723
Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis (PREDICTORS)
Thromboembolic Disease Recurrent · Deep Vein Thrombosis · Pulmonary Embolism · Venous Thromboembolism · Recurrent Thromboembolic Disease
Bottom Line
View on ClinicalTrials.gov: NCT02297373 ↗Enrolled (actual)
723
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Validation of the Wells DVT Clinical Decision Rule — 67; 186; 148; 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Validation of the Wells DVT Clinical Decision Rule |
67; 186; 148; 4; 39; 65 | — |
| PRIMARY Validation of the Wells PE Clinical Decision Rule |
83; 160; 25; 11; 56; 12 | — |
| PRIMARY Validation of the Geneva PE Clinical Decision Rule |
46; 181; 41; 2; 56; 21 | — |
| SECONDARY Accuracy of Current D-dimer Testing Methods |
6; 163 | — |
| SECONDARY Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy |
1; 9; 17; 1; 7; 3 | — |
| SECONDARY All-Cause Mortality Within 90 Days of Index Visit |
9 | — |
Summary
Patients with a history of blood clots are at risk of developing additional clots in the future. Doctors use a tool called a clinical decision rule to tell them how likely it is that a patient has a blood clot and if they should have further testing to look for the clot. This tool may cause doctors to over-diagnosis a recurrent clot because the symptoms may be left over from the previous clot. Correctly diagnosing a recurrent blood clot is very important since there are risks associated with both over-diagnosis and under-diagnosis. If a recurrent blood clot is missed (under-diagnosis) the patient is at risk of death from a clot in the lungs. If blood thinners are prescribed when they are not needed (over-diagnosis), the patient may have to take blood thinners for their lifetime and risk having serious bleeding.
Eligibility Criteria
Inclusion Criteria
- Outpatients with clinically suspected acute recurrent DVT or PE regardless of whether the previous event was a DVT or PE
- Age ≥18 years old
- Willing and able to give informed consent
Exclusion Criteria
- Life expectancy less than 3 months
- Suspicion of upper extremity thrombosis or thrombosis at an unusual site (e.g. cerebral or abdominal venous thrombosis)
- Previous VTE was distal DVT or subsegmental PE
- Suspected recurrent VTE is asymptomatic
- Previously enrolled in this study
Data sourced from ClinicalTrials.gov (NCT02297373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.