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

Pulmonary Embolism Clinical Trial

— PREDICTORS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297373
• Other study ID #: 20140622-01H
• Status: Completed
• Start date: November 19, 2014
• Est. completion date: January 3, 2019

Study information

• Verified date: September 2021
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Lawson Health Research Institute	London	Ontario
Canada	Sir Mortimer B. Davis Jewish General Hospital	Montreal	Quebec
Canada	Hopital Montfort	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Netherlands	Leiden University Medical Centre	Leiden
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Countries where clinical trial is conducted

Canada,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the Wells DVT clinical decision rule	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).	3 years
Primary	Validation of the Wells PE clinical decision rule	The rate of confirmed recurrent events using the Wells PE CDR will be analyzed for patients with a clinically suspected recurrent Venous Thromboembolism (VTE).	3 years
Primary	Validation of the Geneva PE clinical decision rule	The rate of confirmed recurrent events using the Geneva PE CDR will be analyzed for patients with a clinically suspected recurrent Venous Thromboembolism (VTE).	3 years
Secondary	Clinical decision rule for suspected VTE in patients with a history of VTE	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.	3 years
Secondary	Accuracy of current D-dimer testing methods	The rate of confirmed events using the current D-dimer cut-offs. Testing methods will be evaluated in patients with suspected recurrent VTE.	3 years
Secondary	Rate of confirmed events using current Wells DVT/Wells PE/Geneva PE in participants on anticoagulant therapy	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.	3 years