The Negative Predictive Value of D-dimer on the Risk of Recurrent Venous Thromboembolism in Patients With Multiple Previous Events: a Prospective Cohort Study
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Twinkle Singh, M.B.B.S. [2]
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
Objective
Aim of this study is to assess the negative predictive value of D-dimer in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.
Sponsor
Università degli Studi dell'Insubria
Timeline
| Timeline | |
| Start Date | May 2007 |
| End Date | June 2010 |
| Status | Terminated |
The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00428441.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Not provided |
| Study Design | |
| Allocation | Non-Randomized |
| Endpoint | Safety/Efficacy Study |
| Interventional Model | Single Group Assignment |
| Masking | Open Label |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Venous Thromboembolism |
| Intervention | Drug: Warfarin tablets, based on INR levels, according to D-dimer levels |
| Study Arms | Not provided |
| Population Size | 73 |
The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00428441.
Eligibility Criteria
Inclusion Criteria
- Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)
- Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases
- Age > 18 years
- Informed consent provided
Exclusion Criteria
- Pregnancy/puerperium
- One or more episodes of massive pulmonary embolism
- Last event isolated idiopathic pulmonary embolism
- Two or more idiopathic VTE events
- First degree relatives with recurrent VTE
- Right ventricular disfunction or pulmonary hypertension
- Active cancer
- Antiphospholipid antibodies syndrome
- Antithrombin deficiency
- Homozygous Factor V Leiden or G20210A prothrombin mutation
- Heterozygous Factor V Leiden and G20210A prothrombin mutation
- Concomitant congenital thrombophilic mutations
- Concomitant indications to long term oral anticoagulant treatment
- Severe cardiorespiratory insufficiency
- Severe liver or renal disease (creatinine clearance > 2 mg/dL)
- Limited life expectancy
- Geographic inaccessibility
Outcomes
Primary Outcomes
- Recurrent deep vein thrombosis or pulmonary embolism in patients with persistently negative D-dimer levels
- Rate of patients with altered D-dimer levels and temporal distribution of alterations
Secondary Outcomes
- Recurrent deep vein thrombosis or pulmonary embolism in patients who resumed oral anticoagulant therapy
- Incidence of major bleeding in patients who resumed oral anticoagulant therapy
- Mortality