NCT03100071Unknown不适用
A Pilot Study in Cancer Patients With Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in the Upper Extremity Treated With Low Molecular Weight Heparin (LMWH) and Apixaban (Catheter 3)
Michael Kovacs2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Central Line Failure
研究概览
简要总结
Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.
详细描述
Cancer patients who have developed blood clot in the arm that has the central venous catheter will be treated with standard of care blood thinning injection of low molecular weight heparin for 1 week and then for apixaban 5 mg twice daily for the rest of 11 weeks. Data will be collected to see if the central venous catheter "survived" or remained in place and did not have to be taken out because of the clot.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female > 18 years of age.
- •Symptomatic acute upper limb thrombosis in the axillary, subclavian or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or Computerized Tomography (CT) scan.
- •Diagnosis of active malignancy, as defined by patients who are either receiving active treatment, or have metastatic disease or who have been diagnosed within the past two years.
- •Willing to provide written informed consent.
排除标准
- •Presence of dialysis catheters
- •Active bleeding or high risk for major bleeding
- •Platelet Count < 75 x 109/L
- •Creatinine Clearance < 30 mL/min
- •Currently on other anticoagulant with therapeutic intent for another indication
- •Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement
- •Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (2 mg tPA).
- •Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months
- •Treatment for current episode > 7 days with any acceptable anticoagulant therapy
- •Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics)
- •Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid [ASA] and Plavix)
- •If female of childbearing potential: pregnancy and/or breastfeeding
结局指标
主要结局
Central Line Failure
时间窗: within 3 months of study follow-up
Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)
次要结局
- Recurrent Venous Thromboembolism (VTE)(within 3 months of study follow-up)
- Bleeding(within 3 months of study follow-up)
研究者
Michael Kovacs
Associate Professor, Medical Doctor
Lawson Health Research Institute
研究点 (2)
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