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

Completed

• Conditions: Deep Vein Thrombosis; Thromboembolic Disease Recurrent; Recurrent Thromboembolic Disease; Pulmonary Embolism; Venous Thromboembolism

• Registration Number: NCT02297373
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Several tools have been developed to standardize the diagnostic management of a suspected first blood clot. One of these tools is the use of a clinical decision rule. Clinical decision rules have been designed to help clinicians make diagnostic and therapeutic decisions at the bedside. A score is computed on the presence of some criteria from the patient's medical history, clinical signs and symptoms. The score provides the probability of a blood clot. The rules can be used in combinations with a simple blood test - called D-dimer - to identify patients at low risk who don't require diagnostic imaging testing. Benefits include reduced costs, length in hospital and radiation exposure.

Patients with prior blood clots have been shown to be less likely to benefit from the non-invasive testing. Therefore, they often need to undergo imaging tests, which are frequently difficult to interpret in patients with prior blood clots since residual clots are often present and are difficult to distinguish from a recurrent clot.

The objective of this study is to try to prospectively assess the role of existing clinical decision rules in patients with prior blood clots, and to attempt to improve them in order to increase the yield of non-invasive testing and to reduce the risk of over-diagnosis with imaging tests.

With respect to this study, clots within the deep veins of the legs are called deep vein thrombosis (DVT), while clots in the lungs are called pulmonary embolism (PE).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-11-18
• Study Start: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2019-01-03
• Study Completion: 2019-01-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 747

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the Geneva PE clinical decision rule	3 years	The rate of confirmed recurrent events using the Geneva PE CDR will be analyzed for patients with a clinically suspected recurrent Venous Thromboembolism (VTE).
Validation of the Wells DVT clinical decision rule	3 years	The rate of confirmed recurrent events using the Wells DVT clinical decision rule (CDR) will be analyzed for patients with a clinically suspected recurrent Venous Thromboembolism (VTE).
Validation of the Wells PE clinical decision rule	3 years	The rate of confirmed recurrent events using the Wells PE CDR will be analyzed for patients with a clinically suspected recurrent Venous Thromboembolism (VTE).

Secondary Outcome Measures

Name	Time	Method
Rate of confirmed events using current Wells DVT/Wells PE/Geneva PE in participants on anticoagulant therapy	3 years	The rate of confirmed events using Wells DVT/Wells PE/Geneva PE in patients currently being treated with anticoagulant therapy at the time of suspected recurrent VTE will be evaluated.
Clinical decision rule for suspected VTE in patients with a history of VTE	3 years	A new CDR will be derived specific to patients with a history of VTE. This CDR will require assessment whether it would improve risk stratification as compared with the existing CDRs.
Accuracy of current D-dimer testing methods	3 years	The rate of confirmed events using the current D-dimer cut-offs. Testing methods will be evaluated in patients with suspected recurrent VTE.

Trial Locations

Locations (9)

Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada

Sir Mortimer B. Davis Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands

Hamilton Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Hopital Montfort; 🇨🇦 Ottawa, Ontario, Canada

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Humber River Hospital; 🇨🇦 Toronto, Ontario, Canada

Geneva University Hospital; 🇨🇭 Geneva, Switzerland