D-Dimer Guided Oral Anticoagulant Treatment (OAT)

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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) using a prospective, randomized, and controlled design.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Collaborators: German Federal Ministry of Education and Research; German Research Foundation
• Treatments: Anticoagulants; Fibrin fragment D; Phenprocoumon; Warfarin

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 (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