Left Rule, D-Dimer Measurement and Complete Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy.
|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
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 . 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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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
- 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.
- Prospective evaluation of the diagnostic performances of the LEFt rule. [ Time Frame: 3 years ]Prospective validation of the LEFt rule.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708239
|Geneva University Hospital||Recruiting|
|Geneva, Switzerland, 1205|
|Contact: Marc Righini, MD +41 22 372 92 94 email@example.com|
|Contact: Helia Robert-Ebadi, MD +41 22 372 92 92 firstname.lastname@example.org|
|Principal Investigator: Marc Righini, MD|
|Principal Investigator:||Grégoire Le Gal, MD||The Ottawa Hospital|