D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism
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|ClinicalTrials.gov Identifier: NCT00428441|
Recruitment Status : Terminated (Enrolment was halted prematurely because of the observed excess in recurrences)
First Posted : January 30, 2007
Results First Posted : September 26, 2011
Last Update Posted : September 26, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: Warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||May 2011|
- Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels [ Time Frame: 1 year ]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 ]
- Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy [ Time Frame: 3 months ]
- Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy [ Time Frame: 3 months ]
- Mortality [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|