Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02297373
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Thromboembolic Disease Recurrent Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism Recurrent Thromboembolic Disease

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 745 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients presenting with suspected acute recurrent VTE.
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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
Hopital Montfort
Ottawa, Ontario, Canada, K1K 0T2
Humber River Hospital
Toronto, Ontario, Canada, M3M 0B2
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Switzerland
Geneva University Hospital
Geneva, Switzerland
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Gregoire Le Gal, MD Ottawa Hospital
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02297373    
Other Study ID Numbers: 20140622-01H
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases