NCT00981903终止2 期
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Development of recurrent venous thromboembolism and major hemorrhage.
研究概览
简要总结
In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.
详细描述
The purpose of this study is to use long-term administration of a low molecular weight heparin (tinzaparin) for primary treatment and secondary prophylaxis of venous thromboembolism in patients with cancer. We will determine the efficacy (recurrent VTE) and safety (major hemorrhage) of this approach. Secondarily, we will analyze the outcome of patients in terms of survival and response to therapy versus matched controls. We will also determine baseline levels of markers of hemostasis, fibrinolysis, and angiogenesis and will follow changes with treatment as well as correlate levels of these plasma markers with outcomes, including recurrent venous thromboembolism, major hemorrhage,and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of active cancer
- •Patients have documented or recurrent malignancy and must meet at least one of the following criteria:
- •Diagnosis or documented presence of cancer within 6 months, excluding squamous cell or basal cell carcinoma of the skin OR
- •Receive any therapy for cancer within the previous 6 months OR
- •Currently receiving any treatment (surgery, radiation, chemotherapy, hormonal therapy, biotherapy, palliative therapy, and/or combined modality therapy) for cancer
- •Documented first venous thromboembolic event
- •Patients must meet at least one of the following criteria:
- •Deep vein thrombosis of the lower extremity confirmed with duplex ultrasonography, magnetic resonance imaging, or venogram OR
- •Pulmonary embolism confirmed with high probability V/Q scan, CT angiogram, or pulmonary angiogram
- •ECOG performance status of 0, 1, or 2
- •Signed written informed consent
- •Age 18 years or greater
排除标准
- •Body weight less than 40 kg
- •Recurrent spontaneous fractures unrelated to the underlying active malignancy
- •Administration of therapeutic doses of unfractionated or low molecular weight heparin for more than 48 hours prior to registration Amendment 3 (05/26/2009) 11
- •Need for long-term oral anticoagulant therapy (e.g., mechanical heart valves, atrial fibrillation)
- •Poor performance status with an ECOG score of 3 or 4
- •Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 2 weeks of presentation
- •Known acute (symptomatic or active bleeding) gastroduodenal ulcer
- •Epidural/spinal puncture within the last 24 hours
- •Neurosurgery within 1 week of registration or any previous history of intracranial hemorrhage
- •Septic endocarditis
- •Overt pericardial effusion
- •Current platelet count of less than 50 x 109/L
- •Undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia, or has other conditions associated with persistent thrombocytopenia of less than 100 109/L for a duration of at least four consecutive weeks
- •Familial bleeding diathesis
- •Uncontrolled hypertension despite antihypertensive therapy
- •Dependent upon renal dialysis or significant renal failure with a serum creatinine of greater than three times the upper limit of normal
- •Allergy to heparin (unfractionated or low molecular weight)
- •Allergy to contrast medium
- •Pregnant or of childbearing potential and not using adequate contraception
- •Geographically inaccessible for follow-up
- •Failure or inability to give informed consent
研究组 & 干预措施
VTE Treatment Group
Experimental
干预措施: Tinzaparin sodium (Drug)
结局指标
主要结局
Development of recurrent venous thromboembolism and major hemorrhage.
时间窗: up to 6 months on treatment
次要结局
- Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis(6 months)
研究者
研究点 (2)
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