A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse Outcomes
研究概览
简要总结
The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.
详细描述
The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without an inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms. Patients will be equally randomized to receive either Arixtra with or without placement of an Inferior Vena Cava (IVC) filter. Fifty three patients are expected to be enrolled in each arm. Patients will be monitored for 90 days after study enrollment. Monitoring will include telephone calls and physician visits and repeat radiologists if the patient is symptomatic of a Deep Vein thrombosis (DVT). This will also include completion of a quality of life questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Documentation of cancer.
- •The disease may be a solid tumor, Lymphoma or Multiple Myeloma. Pathology reports will be documented in the patient's chart and included in the data.
- •Age > 18 years
- •An acute, radiographically confirmed, de novo Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
- •No past medical history of a prior thrombus or known thrombophilia
- •Exclusion Criteria
- •Patients are not eligible for this study if they receive therapeutic doses of any heparin for more than 72 hours before randomization
- •Already receiving oral anticoagulant therapy
- •Severe renal impairment, calculated using the Cockcroft-Gault formula, defined as a creatinine clearance <30 mL/min
- •Platelet count of less than 50,000 per cubic millimeter
- •Bleeding from the gastrointestinal tract that requires blood transfusion (s), intracranial bleeding or retroperitoneal bleeding.
- •An indication for thrombolysis
- •Allergy to iodine
- •Hereditary thrombophilia
- •Pregnancy
- •Likelihood of noncompliance
- •It is contraindicated to anticoagulate patients with brain metastasis secondary to melanoma, choriocarcinoma, renal cell and medullary thyroid carcinoma. If these patients have a Venous Thromboembolism (VTE), it is standard of care for these patients to have a CT of their head to evaluate if there is metastasis to the brain before they are anticoagulated
- •If these patients do have brain metastasis, they will not be included in the study.
排除标准
- 未提供
研究组 & 干预措施
1- Arixtra Alone
Arixtra Alone
干预措施: Arixtra alone (Drug)
2 Arixtra+ filter
Arixtra + filter
干预措施: Arixtra + filter (Device)
结局指标
主要结局
Adverse Outcomes
时间窗: 3 years or until death
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs
次要结局
- Overall Survival(3 years or until death)
- Resolution of DVT(3 years or until death)
- Resolution of PE(3 years or until death)
研究者
Daniel Budman
Interim Chief, Division of Oncology
Northwell Health