Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis (PREDICTORS) (PREDICTORS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02297373|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : September 16, 2020
|Condition or disease|
|Thromboembolic Disease Recurrent Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism Recurrent Thromboembolic Disease|
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).
|Study Type :||Observational|
|Estimated Enrollment :||745 participants|
|Official Title:||Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis|
|Actual Study Start Date :||November 19, 2014|
|Actual Primary Completion Date :||January 3, 2019|
|Estimated Study Completion Date :||July 2021|
- Validation of the Wells DVT clinical decision rule [ Time Frame: 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 [ Time Frame: 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).
- Validation of the Geneva PE clinical decision rule [ Time Frame: 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).
- Clinical decision rule for suspected VTE in patients with a history of VTE [ Time Frame: 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 [ Time Frame: 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.
- Rate of confirmed events using current Wells DVT/Wells PE/Geneva PE in participants on anticoagulant therapy [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297373
|Canada, Nova Scotia|
|Nova Scotia Health Authority|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Hamilton Health Sciences Centre|
|Hamilton, Ontario, Canada, L8L 2X2|
|Lawson Health Research Institute|
|London, Ontario, Canada, N6G 4A5|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Ottawa, Ontario, Canada, K1K 0T2|
|Humber River Hospital|
|Toronto, Ontario, Canada, M3M 0B2|
|Sir Mortimer B. Davis Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Leiden University Medical Centre|
|Geneva University Hospital|
|Principal Investigator:||Gregoire Le Gal, MD||Ottawa Hospital|