Deep Venous Thrombosis
Conditions
Keywords
DVT, Venous thromboembolism, D-Dimer, thrombophilia, secondary prophylaxis, secondary prophylaxis using oral anticoagulant treatment (OAT), higher risk of recurrence in patients showing increased levels, of D-Dimer after withdrawal of OAT, D-Dimer-based treatment
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) using a prospective, randomized, and controlled design.
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 treatment (OAT) is usually established in these patients. This treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. Major bleeding complications can be expected in \ 2% patient-years. Therefore, current recommendations limit OAT to a period of 3 to 12 months. After stopping of OAT, however, \ 10 % of patients with an initial episode of unprovoked DVT will develop a recurrent event within 1 year. This group of patients may benefit from prolonged OAT. The results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of D-Dimer after withdrawal of OAT. D-Dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. Based on these data we hypothesize that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of DVT. This clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design.
Interventions
DRUGPhenprocoumon
Phenprocoumon 3 mg, tablet, INR adjusted
DRUGWarfarin-Natrium
Warfarin-Natrium 5 mg, tablet, INR adjusted
Sponsors
German Research Foundation
German Federal Ministry of Education and Research
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE) | Duration of intervention per patient (24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of signs and symptoms associated with OAT-induced bleeding measured using the World Health Organization (WHO) bleeding scale. | Duration of intervention per patient (24 months) |
Countries
Germany
Contacts
Primary ContactBernd Poetzsch, Professor
Outcome results
None listed