D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study|
- Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis
- Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428441
|University Of Insubria|
|Varese, Italy, 21100|
|Study Chair:||Gualtiero Palareti||University of Bologna|
|Study Director:||Walter Ageno||Università degli Studi dell'Insubria|
|Study Director:||Vittorio Pengo||University of Padua|