Safety and Efficacy of a D-Dimer-Guided Strategy for Extension of Secondary Prophylaxis of Venous Thromboembolism - a Prospective and Randomized Management Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
oral anticoagulants
Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis.
干预措施: Phenprocoumon (Drug)
oral anticoagulants
Experimental intervention: Extension of OAT in VTE patients showing high plasma levels of D-Dimer after end of routine secondary prophylaxis.
干预措施: Warfarin-Natrium (Drug)
结局指标
主要结局
Incidence and severity of objectively documented deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
时间窗: Duration of intervention per patient (24 months)
次要结局
- 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))