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

NCT01708239 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-05-04

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Deep Vein Thrombosis

Interventions

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

Sponsors & Collaborators

  • University Hospital, Brest

    collaborator OTHER

  • The Ottawa Hospital

    collaborator OTHER

  • Marc Righini

    lead OTHER

Principal Investigators

  • Grégoire Le Gal, MD · The Ottawa Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01708239 on ClinicalTrials.gov