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Left Rule, D-Dimer Measurement and Complete Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy.

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ClinicalTrials.gov Identifier: NCT01708239
Recruitment Status : Unknown
Verified May 2015 by Marc Righini, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : October 16, 2012
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

In pregnant women with suspected DVT, a sure diagnosis is mandatory. In non-pregnant patients, sequential diagnostic strategies based on 1) the assessment of clinical probability, 2) D-dimer measurement and 3) compression ultrasonography (CUS) have been well validated.

Clinical probability assessment by clinical prediction rules (CPRs) is a crucial step in the management of suspected DVT. However, the most commonly used CPR for DVT, the Wells' score, has never been validated in pregnant women. Recently, the 'LEFt' clinical prediction rule was derived and internally validated. A prospective validation of this rule is now warranted, and we plan to use it in our prospective study.

The second step used in the diagnostic strategy including non-pregnant patients is D-dimer measurement. The test has been widely validated in non-pregnant patients and, in association with a non-high clinical probability, it allows to safely rule out DVT.

As D-dimer level raise steadily during pregnancy, the specificity of the test decreases and it is less useful in pregnant women. Data from the literature clearly suggest that the usual cut-off set a 500 ng/ml would safely rule out DVT in pregnant women [6]. As the usual cut-off has never been prospectively validated in pregnant women with suspected DVT, we would like to use it in our study.

Some studies suggested that complete CUS is safe to rule out DVT in pregnant women. However, this test is not always available. Therefore, a strategy in which the association of clinical probability assessment and D-dimer measurement would allow to safely rule out DVT in a significant proportion of patients without performing a complete CUS, would be of great help in everyday clinical practice and would probably be cost-effective.

Therefore, we plan a prospective study to assess the safety of a sequential diagnostic strategy based on the assessment of clinical probability with the LEFt rule, D-dimer measurement and complete CUS in pregnant women with suspected DVT.


Condition or disease Intervention/treatment
Pregnancy Deep Vein Thrombosis Other: Left rule, D-dimer measurement and complete ultrasonography in pregnant women.

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sequential Use of the LEFt Rule, D-dimer Measurement and Complete Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy: a Prospective Outcome Study.
Study Start Date : October 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : January 2016

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Pregnant women
Pregnant women with suspected DVT assessed by the LEFt rule, D-dimer measurement and complete ultrasonography.
Other: Left rule, D-dimer measurement and complete ultrasonography in pregnant women.
Diagnostic strategy based on the LEFt rule, D-dimer measurement and complete ultrasonography


Outcome Measures

Primary Outcome Measures :
  1. The main outcome will be the number of thromboembolic recurrent events (DVT, PE, death attributable to venous thromboembolic disease) documented during the three-month follow-up in the patients left untreated on the basis of a normal diagnostic strategy. [ Time Frame: 3 years ]
    Rate of thromboembolic events after a normal diagnostic strategy.


Secondary Outcome Measures :
  1. Prospective evaluation of the diagnostic performances of the LEFt rule. [ Time Frame: 3 years ]
    Prospective validation of the LEFt rule.

  2. Prospective evaluation of D-dimer measurement to rule out DVT in pregnant women. [ Time Frame: 3 years ]
    Prospective evaluation of the diagnostic performances of D-dimer measurement in pregnant women with suspected DVT.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with suspected DVT
Criteria

Inclusion Criteria:

Pregnant women with clinically suspected DVT

Exclusion Criteria:

  • Age less than 18
  • No available informed consent
  • Associated suspicion of pulmonary embolism
  • Ongoing anticoagulant treatment
  • Planned anticoagulant treatment at therapeutic dosage during pregnancy
Contacts and Locations

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): NCT01708239


Locations
Switzerland
Geneva University Hospital Recruiting
Geneva, Switzerland, 1205
Contact: Marc Righini, MD    +41 22 372 92 94    marc.righini@hcuge.ch   
Contact: Helia Robert-Ebadi, MD    +41 22 372 92 92    helia.robert-ebadi@hcuge.ch   
Principal Investigator: Marc Righini, MD         
Sponsors and Collaborators
Marc Righini
University Hospital, Brest
The Ottawa Hospital
Investigators
Principal Investigator: Grégoire Le Gal, MD The Ottawa Hospital
More Information

Responsible Party: Marc Righini, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01708239     History of Changes
Other Study ID Numbers: Geneva University Hospital
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Marc Righini, University Hospital, Geneva:
Pregnancy
Deep vein thrombosis
Clinical probability
D-Dimer
Compression ultrasonography

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants