View source for Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial

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{{D-dimer}}

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==Official Title==
Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial

==Objective==
This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design.

==Sponsor==
University Hospital, Bonn
==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%"| February 2008
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| '''End Date'''||February 2012
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| '''Status'''||Unknown
|-
|}
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00895505.</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
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| '''Study Phase''' ||Phase 3
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
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| '''Allocation'''||Randomized
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| '''Endpoint'''||Safety/Efficacy Study
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| '''Interventional Model'''||Parallel 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'''||
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| '''Condition'''||Deep Venous Thrombosis
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| '''Intervention'''||Phenprocoumon 3 mg, tablet, INR adjusted<br>Warfarin-Natrium 5 mg, tablet, INR adjusted
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| '''Study Arms'''||Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis<br>Control: Withdrawal of OAT in VTE patients after end of routine secondary prophylaxis and receiving low molecular weight heparin in risk situations
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| '''Population Size'''||300
|-
|}

<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00895505.</span>

==Eligibility Criteria==
===Inclusion Criteria===
*To be enrolled in this study, patients must:
**Have an objectively confirmed first episode of unprovoked VTE or of VTE during a minor transient risk factor. Minor transient risk factors include 6 weeks of : estrogen therapy, prolonged air travel (i.e., > 6 hours), pregnancy, less marked leg injuries or immobilization without injury or surgical intervention
**Be scheduled to receive oral anticoagulant treatment for at least 3 months
**Be willing to be randomized
**Be willing to participate for the full duration of the study

===Exclusion Criteria===
*Pregnancy or breast feeding
*Contraindications against OAT (Oral Anticoagulant Therapy) (i.e., intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
*Age < 18 years
*Presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i.e., antithrombin deficiency, hereditary PC  deficiency)
*Poor patient compliance
==Outcomes==
===Primary Outcomes===
Incidence and severity of objectively documented deep vein  thrombosis (DVT) and/or pulmonary embolism (PE) [ Time Frame: Duration of intervention per patient (24 months) ] [ Designated as safety issue: Yes ]
===Secondary Outcomes===
Incidence and severity of signs and symptoms associated with OAT-induced bleeding measured using the World Health Organization (WHO) bleeding scale. [ Time Frame: Duration of intervention  per patient (24 months) ] [ Designated as safety issue: Yes ]
==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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