NCT00428441

D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism

The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low. The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels. Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Warfarin	tablets, based on INR levels, according to D-dimer levels

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-06-01
• Completion: 2011-05-01
• First posted: 2007-01-30
• Last updated: 2011-09-26
• Results posted: 2011-09-26

Locations

1 site across 1 country: Italy