Status:
UNKNOWN
D-Dimer Guided Oral Anticoagulant Treatment (OAT)
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
German Research Foundation
German Federal Ministry of Education and Research
Conditions:
Deep Venous Thrombosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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) ...
Detailed Description
After a first episode of acute deep venous thrombosis (DVT) the risk of recurrence is relatively high and clinical consequences are important. Therefore, secondary prophylaxis using oral anticoagulant...
Eligibility Criteria
Inclusion
- 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
- pregnancy or breast feeding
- contraindications against OAT (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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00895505
Start Date
February 1 2008
End Date
February 1 2012
Last Update
May 8 2009
Active Locations (1)
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1
Institut für Experimentelle Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany, 53105