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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital, Geneva
Sponsor:
Collaborators:
University Hospital, Brest
The Ottawa Hospital
Information provided by (Responsible Party):
Marc Righini, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01708239
First received: October 10, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Rate of thromboembolic events after a normal diagnostic strategy.


Secondary Outcome Measures:
  • Prospective evaluation of the diagnostic performances of the LEFt rule. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Prospective validation of the LEFt rule.

  • Prospective evaluation of D-dimer measurement to rule out DVT in pregnant women. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Prospective evaluation of the diagnostic performances of D-dimer measurement in pregnant women with suspected DVT.


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marc Righini, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01708239     History of Changes
Other Study ID Numbers: Geneva University Hospital
Study First Received: October 10, 2012
Last Updated: October 15, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by 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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014