Trial Outcomes & Findings for Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis (PREDICTORS) (NCT NCT02297373)
NCT ID: NCT02297373
Last Updated: 2025-09-05
Results Overview
The Wells DVT Clinical Decision Rule (CDR) assigns a score from -2 to +9 based on clinical variables (e.g., active cancer, limb swelling, localized tenderness, prior history of DVT, alternative diagnosis as likely or more likely than DVT). In this study, the 3-level Wells DVT CDR was applied prospectively at presentation (Day 0) to participants with suspected recurrent DVT, using data collected from patient history and physical examination. Scores classify patients into low (≤0), moderate (1-2), or high (≥3) probability of DVT. Higher scores indicate greater probability of recurrent DVT. The outcome measure was the rate of confirmed recurrent DVT events within each Wells category, confirmed by objective imaging and adjudicated by an independent committee.
COMPLETED
744 participants
Day 0 (at time of suspected recurrent DVT)
2025-09-05
Participant Flow
Between November 2014 to January 2019, eligible patients were recruited from six Canadian teaching hospitals, one academic center in Switzerland and one academic hospital in the Netherlands. All adult outpatients presenting to the Emergency Departments or Thrombosis Clinics of the participating hospitals with signs or symptoms suggestive of recurrent VTE and who were willing and able to give informed consent were eligible for inclusion.
Between Nov 2014 and Jan 2019, 744 participants consented and had baseline data and blood samples collected. Verification of prior VTE history excluded 21 with non-qualifying events, leaving 723 who met eligibility and were included. Those with recurrent VTE diagnosed at enrolment completed participation at the initial visit; those who did not have recurrent VTE diagnosed at enrolment were followed up by phone at Day 90.
Participant milestones
| Measure |
Participant Eligibility
Of the 744 participants who provided informed consent and had baseline data and blood samples collected, 21 were later determined not to meet eligibility criteria after verification of prior VTE history (e.g., superficial vein thrombosis, below-knee DVT, subsegmental PE, or other non-qualifying events). These participants were excluded from analysis, leaving 723 who met all eligibility criteria and were included in the study.
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|---|---|
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Overall Study
STARTED
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723
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Overall Study
COMPLETED
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705
|
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Overall Study
NOT COMPLETED
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18
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
Baseline characteristics by cohort
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=723 Participants
Of the 744 participants consented, 723 met all eligibility criteria and were included in the study.
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|---|---|
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Age, Continuous
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57.7 years
STANDARD_DEVIATION 16.5 • n=723 Participants
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Sex: Female, Male
Female
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367 Participants
n=723 Participants
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Sex: Female, Male
Male
|
356 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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657 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Black
|
30 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
10 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Caucasian and Aboriginal
|
2 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Caucasian and Black
|
2 Participants
n=723 Participants
|
|
Race/Ethnicity, Customized
Caucasian and Asian
|
1 Participants
n=723 Participants
|
|
Body Mass Index
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29.6 kg/m2
STANDARD_DEVIATION 6.8 • n=723 Participants
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Weight
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87.6 kilograms
STANDARD_DEVIATION 21.5 • n=723 Participants
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Current Medication
Aspirin
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104 participants
n=723 Participants
|
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Current Medication
Clopidogrel
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11 participants
n=723 Participants
|
|
Current Medication
Anticoagulation
|
322 participants
n=723 Participants
|
|
Current Medication
Oral estrogen therapy
|
16 participants
n=723 Participants
|
|
Type of Anticoagulation (n)
Warfarin
|
92 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
|
|
Type of Anticoagulation (n)
Rivaroxaban
|
124 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
|
|
Type of Anticoagulation (n)
Dabigatran
|
1 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
|
|
Type of Anticoagulation (n)
Apixaban
|
31 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
|
|
Type of Anticoagulation (n)
Edoxaban
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1 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
|
|
Type of Anticoagulation (n)
Low molecular weight heparin
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66 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
|
|
Type of Anticoagulation (n)
Blinded study drug
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7 Participants
n=322 Participants • Of the 723 participants analyzed, 322 were currently taking an anticoagulant at the time of study inclusion
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Known thrombophilia
Antithrombin deficiency
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3 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Protein C deficiency
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8 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Protein S deficiency
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6 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Heterozygote Factor V Leiden
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46 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Homozygote Factor V Leiden
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1 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Factor V Leiden unknown if heterozygote or homozygote
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5 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Prothrombin gene mutation
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16 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
|
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Known thrombophilia
Lupus anticoagulant
|
8 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
|
|
Known thrombophilia
Anti-cardiolipins
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12 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Known thrombophilia
Anti-Beta 2 glycoprotein 1
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4 participants
n=92 Participants • Of the 723 participants analyzed, 92 had known thrombophilia at the time of study inclusion. Participants could have more than one thrombophilia diagnosed.
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Family History of Venous Thromboembolism (VTE)
Yes
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213 Participants
n=723 Participants
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Family History of Venous Thromboembolism (VTE)
No
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510 Participants
n=723 Participants
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Number of confirmed previous events
1
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559 Participants
n=723 Participants
|
|
Number of confirmed previous events
2
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130 Participants
n=723 Participants
|
|
Number of confirmed previous events
3
|
22 Participants
n=723 Participants
|
|
Number of confirmed previous events
4
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10 Participants
n=723 Participants
|
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Number of confirmed previous events
>/= 5
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2 Participants
n=723 Participants
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Type of last VTE event
Pulmonary embolism (PE)
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237 Participants
n=723 Participants
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Type of last VTE event
Deep vein thrombosis (DVT)
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357 Participants
n=723 Participants
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Type of last VTE event
PE and DVT
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129 Participants
n=723 Participants
|
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Active cancer
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79 participants
n=723 Participants
|
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Smoking status
Current smoker
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104 Participants
n=723 Participants
|
|
Smoking status
Previous smoker
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227 Participants
n=723 Participants
|
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Smoking status
No smoking history
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392 Participants
n=723 Participants
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PRIMARY outcome
Timeframe: Day 0 (at time of suspected recurrent DVT)Population: Of the 723 participants included in the study, 401 presented with suspicion of isolated DVT, without signs or symptoms of PE. Of the 401 presenting with suspicion of isolated DVT, 108 had a confirmed diagnosis of DVT.
The Wells DVT Clinical Decision Rule (CDR) assigns a score from -2 to +9 based on clinical variables (e.g., active cancer, limb swelling, localized tenderness, prior history of DVT, alternative diagnosis as likely or more likely than DVT). In this study, the 3-level Wells DVT CDR was applied prospectively at presentation (Day 0) to participants with suspected recurrent DVT, using data collected from patient history and physical examination. Scores classify patients into low (≤0), moderate (1-2), or high (≥3) probability of DVT. Higher scores indicate greater probability of recurrent DVT. The outcome measure was the rate of confirmed recurrent DVT events within each Wells category, confirmed by objective imaging and adjudicated by an independent committee.
Outcome measures
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=401 Participants
A total of 744 participants provided informed consent. After verification of prior VTE history, 21 were excluded from analyses, leaving 723 in the study cohort. This outcome includes all participants assessed with the 3-level Wells DVT clinical decision rule at presentation for suspected recurrent DVT.
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|---|---|
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Validation of the Wells DVT Clinical Decision Rule
Suspicion of Recurrent DVT · Score </= 0 (low)
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67 Participants
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Validation of the Wells DVT Clinical Decision Rule
Suspicion of Recurrent DVT · Score >/= 1-2 (moderate)
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186 Participants
|
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Validation of the Wells DVT Clinical Decision Rule
Suspicion of Recurrent DVT · Score >/= 3 (high)
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148 Participants
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Validation of the Wells DVT Clinical Decision Rule
Confirmed DVT during follow-up period · Score </= 0 (low)
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4 Participants
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Validation of the Wells DVT Clinical Decision Rule
Confirmed DVT during follow-up period · Score >/= 1-2 (moderate)
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39 Participants
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Validation of the Wells DVT Clinical Decision Rule
Confirmed DVT during follow-up period · Score >/= 3 (high)
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65 Participants
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PRIMARY outcome
Timeframe: Day 0 (at time of suspected recurrent PE)Population: Of the 723 participants enrolled, 268 presented with a suspicion of recurrent PE without concomitant DVT suspicion. Of the 268 presenting with suspicion of isolated PE, 79 had a confirmed diagnosis of PE.
The 3-level Wells PE score (range 0-12.5) was calculated from history and exam at the index visit. Scores ≤4 = PE unlikely, \>4 = PE likely. Higher scores indicate greater likelihood of PE. The outcome is the proportion with confirmed recurrent PE at the index diagnostic work-up, adjudicated by blinded review of imaging.
Outcome measures
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=268 Participants
A total of 744 participants provided informed consent. After verification of prior VTE history, 21 were excluded from analyses, leaving 723 in the study cohort. This outcome includes all participants assessed with the 3-level Wells DVT clinical decision rule at presentation for suspected recurrent DVT.
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|---|---|
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Validation of the Wells PE Clinical Decision Rule
Suspicion of PE · Score <2 (low)
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83 Participants
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Validation of the Wells PE Clinical Decision Rule
Suspicion of PE · Score 2-6 (moderate)
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160 Participants
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Validation of the Wells PE Clinical Decision Rule
Suspicion of PE · Score >6 (high)
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25 Participants
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Validation of the Wells PE Clinical Decision Rule
VTE recurrence confirmed during follow-up · Score <2 (low)
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11 Participants
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Validation of the Wells PE Clinical Decision Rule
VTE recurrence confirmed during follow-up · Score 2-6 (moderate)
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56 Participants
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Validation of the Wells PE Clinical Decision Rule
VTE recurrence confirmed during follow-up · Score >6 (high)
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12 Participants
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PRIMARY outcome
Timeframe: Day 0 (at time of suspected recurrent PE)Population: Of the 723 participants included in the study, 268 presented with suspicion of PE, without signs or symptoms of DVT. Of the 268 presenting with suspicion of isolated PE, 79 had a confirmed diagnosis of PE.
The revised Geneva score (range 0-22) was calculated from history and exam at the index visit. Scores 0-3 = low, 4-10 = intermediate, ≥11 = high probability. Higher scores indicate greater likelihood of PE. The outcome is the proportion with confirmed recurrent PE at the index diagnostic work-up, adjudicated by blinded review of imaging.
Outcome measures
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=268 Participants
A total of 744 participants provided informed consent. After verification of prior VTE history, 21 were excluded from analyses, leaving 723 in the study cohort. This outcome includes all participants assessed with the 3-level Wells DVT clinical decision rule at presentation for suspected recurrent DVT.
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|---|---|
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Validation of the Geneva PE Clinical Decision Rule
Suspicion of recurrent PE · Score 0-3 (low)
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46 Participants
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Validation of the Geneva PE Clinical Decision Rule
Suspicion of recurrent PE · Score 4-10 (intermediate)
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181 Participants
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Validation of the Geneva PE Clinical Decision Rule
Suspicion of recurrent PE · Score >/= 11 (high)
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41 Participants
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Validation of the Geneva PE Clinical Decision Rule
Confirmed diagnosis of PU · Score 0-3 (low)
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2 Participants
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Validation of the Geneva PE Clinical Decision Rule
Confirmed diagnosis of PU · Score 4-10 (intermediate)
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56 Participants
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Validation of the Geneva PE Clinical Decision Rule
Confirmed diagnosis of PU · Score >/= 11 (high)
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21 Participants
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SECONDARY outcome
Timeframe: Day 0 (at time of suspected recurrent VTE)Population: Of the 723 participants in the study cohort, the attending physician ordered D-dimer testing in 482 at presentation for suspected recurrent VTE. This outcome measure is based on the 169 participants from that group who had negative D-dimer results and were evaluated for recurrent VTE.
D-dimer testing at the index visit was performed using the institutional cut-off for positivity in place during the study period (2014-2019). Results were classified as positive or negative. The outcome is the proportion with confirmed recurrent VTE in each test category at the index diagnostic work-up, adjudicated by blinded review of imaging.
Outcome measures
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=169 Participants
A total of 744 participants provided informed consent. After verification of prior VTE history, 21 were excluded from analyses, leaving 723 in the study cohort. This outcome includes all participants assessed with the 3-level Wells DVT clinical decision rule at presentation for suspected recurrent DVT.
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|---|---|
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Accuracy of Current D-dimer Testing Methods
Negative D-dimer with recurrent VTE diagnosed
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6 Participants
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Accuracy of Current D-dimer Testing Methods
Negative D-dimer with no recurrent VTE diagnosed
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163 Participants
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SECONDARY outcome
Timeframe: Day 0 (at time of suspected recurrent VTE)Population: Of the 723 participants included, 38 were receiving anticoagulant therapy at the time of study inclusion and had a confirmed recurrent VTE. Of the 38 confirmed recurrent VTE events, 27 were for recurrent DVT and 11 were recurrent PE.
The Wells DVT, Wells PE, and Geneva PE scores were calculated at the index visit in participants on anticoagulation. Score ranges and cut-offs as per respective rules. The outcome is the proportion with confirmed recurrent VTE in each risk category at the index diagnostic work-up, adjudicated by blinded review of imaging.
Outcome measures
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=38 Participants
A total of 744 participants provided informed consent. After verification of prior VTE history, 21 were excluded from analyses, leaving 723 in the study cohort. This outcome includes all participants assessed with the 3-level Wells DVT clinical decision rule at presentation for suspected recurrent DVT.
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|---|---|
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed DVT using 3-level Wells Score · Low
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1 Participants
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed DVT using 3-level Wells Score · Moderate/Intermediate
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9 Participants
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed DVT using 3-level Wells Score · High
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17 Participants
|
|
Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed PE using 3-level Wells Score · Low
|
1 Participants
|
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed PE using 3-level Wells Score · Moderate/Intermediate
|
7 Participants
|
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed PE using 3-level Wells Score · High
|
3 Participants
|
|
Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed PE using revised Geneva Score · Low
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0 Participants
|
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed PE using revised Geneva Score · Moderate/Intermediate
|
10 Participants
|
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Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy
Patients on anticoagulation with confirmed PE using revised Geneva Score · High
|
1 Participants
|
SECONDARY outcome
Timeframe: From enrollment (Day 0) through Day 90 follow-up for those not diagnosed with a confirmed recurrent VTE at enrollmentNumber of participants who died from any cause from enrollment (Day 0) through Day 90 follow-up for those without confirmed recurrent VTE at enrollment.
Outcome measures
| Measure |
Patients Presenting With Suspicion of Recurrent Venous Thromboembolism
n=723 Participants
A total of 744 participants provided informed consent. After verification of prior VTE history, 21 were excluded from analyses, leaving 723 in the study cohort. This outcome includes all participants assessed with the 3-level Wells DVT clinical decision rule at presentation for suspected recurrent DVT.
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|---|---|
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All-Cause Mortality Within 90 Days of Index Visit
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9 Participants
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Adverse Events
All-cause Mortality
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place