View source for 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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{{D-dimer}}

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==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==
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
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| Style="width:30%"| '''Start Date'''||Style="width:70%"| May 2007
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| '''End Date'''||June 2010
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| '''Status'''||Terminated
|-
|}
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00428441.</span>

==Study Description==

{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
|-
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional
|-
| '''Study Phase''' ||Not provided
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
|-
| '''Allocation'''|| Non-Randomized
|-
| '''Endpoint'''|| Safety/Efficacy Study
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| '''Interventional Model'''||Single Group Assignment
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| '''Masking'''||Open Label
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
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| '''Primary Purpose'''||Treatment
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| '''Condition'''||Venous Thromboembolism
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| '''Intervention'''||Drug: Warfarin tablets, based on INR levels, according to D-dimer levels
|-
| '''Study Arms'''||Not provided
|-
| '''Population Size'''||73
|-
|}

<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00428441.</span>

==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

==Publications==
===Results===

===Conclusion===

==References==
{{Reflist|2}}

[[Category:Laboratory Test]]
[[Category:Chemical pathology]]
[[Category:Hematology]]
[[Category:Fibrinolytic system]]
[[Category:Cardiology]]
[[Category:Pulmonology]]

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