Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis (PREDICTORS)

NCT02297373 | Completed Results

• 1 other identifier: 20140622-01H
• Study Type: observational
• Target: 744
• Locations: 3 countries
• Sites: 9

Brief 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.

Conditions

Thromboembolic Disease Recurrent; Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism; Recurrent Thromboembolic Disease

Outcome Measures

Primary Outcomes (3)

• Validation of the Wells DVT Clinical Decision Rule

  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.

  Day 0 (at time of suspected recurrent DVT)

• Validation of the Wells PE Clinical Decision Rule

  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.

  Day 0 (at time of suspected recurrent PE)

• Validation of the Geneva PE Clinical Decision Rule

  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.

  Day 0 (at time of suspected recurrent PE)

Secondary Outcomes (3)

• Accuracy of Current D-dimer Testing Methods

  Day 0 (at time of suspected recurrent VTE)

• Rate of Confirmed Events Using Current Wells DVT/Wells PE/Geneva PE in Participants on Anticoagulant Therapy

  Day 0 (at time of suspected recurrent VTE)

• All-Cause Mortality Within 90 Days of Index Visit

  From enrollment (Day 0) through Day 90 follow-up for those not diagnosed with a confirmed recurrent VTE at enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients presenting with suspected acute recurrent venous thromboembolism (VTE).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (9)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L 2X2, Canada

Location

Lawson Health Research Institute

London, Ontario, N6G 4A5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Hopital Montfort

Ottawa, Ontario, K1K 0T2, Canada

Location

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Leiden University Medical Centre

Leiden, Netherlands

Location

Geneva University Hospital

Geneva, Switzerland

Location

Related Publications (1)

• Mai V, Martens ESL, Righini M, Schulman S, Thiruganasambandamoorthy V, Kahn SR, Pecarskie A, Kovacs MJ, Visser S, Shivakumar S, Tan M, Kearon C, Rodger M, Scarvelis D, Delluc A, Girard P, Huisman MV, Wells PS, Klok FA, Le Gal G; PREDICTORS study group. Performance of clinical decision rules in patients presenting with suspected recurrent venous thromboembolism: a multicenter prospective cohort study. J Thromb Haemost. 2025 Oct;23(10):3239-3250. doi: 10.1016/j.jtha.2025.06.019. Epub 2025 Jun 25.

  PMID: 40578691 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism; Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Results Point of Contact

• Title: Dr Gregoire Le Gal
• Organization: Ottawa Hospital

glegal@toh.ca

613-737-8899

Study Officials

• Gregoire Le Gal, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: November 21, 2014
• Study Start: November 19, 2014
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Locations

NL (1); CH (1); CA (7)